FDA releases November PMA approvals

Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P090012 11/1/11	MelaFind®	MELA Sciences, Inc. Irving, NY 10533	Approval for the MelaFind device. MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma. MelaFind is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should NOT be used to confirm a clinical diagnosis of melanoma. MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the appropriate use of MelaFind. The MelaFind result is one element of the overall clinical assessment. MelaFind positive lesions (which may include malignant melanoma, melanoma in situ, high grade dysplastic nevi and atypical melanocytic proliferation/hyper-plasia) should be considered for biopsy; the biopsy decision of a MelaFind negative lesion should be based on the remainder of the entire clinical context. Lesions that are "non-evaluable" by MelaFind should be carefully re-evaluated for biopsy. MelaFind is indicated only for use on lesions with a diameter between 2 mm and 22 mm, lesions that are accessible by the MelaFind imager, lesions that are sufficiently pigmented (i.e. not for use on non-pigmented or skin-colored lesions), lesions that do not contain a scar or fibrosis consistent with previous trauma, lesions where the skin is intact (Le., non-ulcerated or non-bleeding lesions), lesions greater than 1 cm away from the eye, lesions which do not contain foreign matter, and lesions not on special anatomic sites (ie., not for use on acral, palmar, plantar, mucosal, or subungual areas). MelaFind is not designed to detect pigmented non-melanoma skin cancers, so the dermatologist should rely on clinical experience to diagnose such lesions.
P090016 11/14/11	BELOTERO Balance	Merz Pharmaceuticals, LLC Greensboro, NC 27410	Approval for BELOTERO Balance. This device is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds.
P100024 11/30/11	HER2 CISH pharmDx™ Kit	Dako Denmark A/S Glostrup, Denmark DK-2600	Approval for the HER2 CISH pharmDx™ Kit. This device is indicated for: HER2 CISH pharmDx™ Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The Kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens. Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments. HER2 CISH pharmDx™ Kit is indicated as an aid in the assessment of patients for whom Herceptin™ (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx™ Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.
P100041 11/2/11	Edwards SAPIEN™ Transcatheter Heart Valve	Edwards Lifesciences, LLC Irvine, CA 92614	Approval for the SAPIEN™ Transcatheter Heart Valve, model 9000TFX, sizes 23mm and 26mm and accessories. This device is indicated for transfemoral delivery in patients with severe symptomatic native aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis.
P110010 11/22/11	PROMUS® Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire)	Boston Scientific Corporation Maple Grove, MN 55311	Approval for the PROMUS® Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System. This device is indicated for improving luminal diameter in patients with symptomatic heart disease due to de novo lesions in native coronary arteries ≥ 2.25 mm to ≤ 4.00 mm in diameter in lesions ≤ 28 mm in length.
P110019 11/1/11	XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System	Abbott Vascular, Inc. Santa Clara, CA 95054	Approval for the XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System. This device is indicated for improving coronary luminal diameter in patients with symptomatic heart disease due to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of ≥ 2.25 mm to ≤ 4.25 mm.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P090012

11/1/11

MelaFind®

MELA Sciences, Inc.

Irving, NY

10533

Approval for the MelaFind device. MelaFind is intended for use on clinically atypical cutaneous pigmented lesions with one or more clinical or historical characteristics of melanoma, excluding those with a clinical diagnosis of melanoma or likely melanoma. MelaFind is designed to be used when a dermatologist chooses to obtain additional information for a decision to biopsy. MelaFind should NOT be used to confirm a clinical diagnosis of melanoma.

MelaFind is only for use by physicians trained in the clinical diagnosis and management of skin cancer (i.e., dermatologists) who have also successfully completed a training program in the

appropriate use of MelaFind.

The MelaFind result is one element of the overall clinical assessment. MelaFind positive

lesions (which may include malignant melanoma, melanoma in situ, high grade dysplastic nevi

and atypical melanocytic proliferation/hyper-plasia) should be considered for biopsy; the biopsy

decision of a MelaFind negative lesion should be based on the remainder of the entire clinical context. Lesions that are "non-evaluable" by MelaFind should be carefully re-evaluated for biopsy.

MelaFind is indicated only for use on lesions with a diameter between 2 mm and 22 mm,

lesions that are accessible by the MelaFind imager, lesions that are sufficiently pigmented (i.e. not for use on non-pigmented or skin-colored lesions), lesions that do not contain a scar or

fibrosis consistent with previous trauma, lesions where the skin is intact (Le., non-ulcerated or non-bleeding lesions), lesions greater than 1 cm away from the eye, lesions which do not

contain foreign matter, and lesions not on special anatomic sites (ie., not for use on acral,

palmar, plantar, mucosal, or subungual areas). MelaFind is not designed to detect pigmented non-melanoma skin cancers, so the dermatologist should rely on clinical experience to diagnose such lesions.

P090016

11/14/11

BELOTERO Balance

Merz Pharmaceuticals, LLC

Greensboro, NC

27410

Approval for BELOTERO Balance. This device is indicated for injection into the mid-to-deep dermis for correction of moderate-to-severe facial wrinkles and folds such as nasolabial folds.

P100024

11/30/11

HER2 CISH pharmDx™ Kit

Dako Denmark A/S

Glostrup, Denmark

DK-2600

Approval for the HER2 CISH pharmDx™ Kit. This device is indicated for:

HER2 CISH pharmDx™ Kit is intended for dual-color chromogenic visualization of signals achieved with directly labeled in situ hybridization probes targeting the HER2 gene and centromeric region of chromosome 17. The Kit is designed to quantitatively determine HER2 gene status in formalin-fixed, paraffin-embedded breast cancer tissue specimens.

Red and blue chromogenic signals are generated on the same tissue section for evaluation under bright field microscopy. The CISH procedure is automated using Dako Autostainer instruments.

HER2 CISH pharmDx™ Kit is indicated as an aid in the assessment of patients for whom Herceptin™ (trastuzumab) treatment is being considered. Results from the HER2 CISH pharmDx™ Kit are intended for use as an adjunct to the clinicopathologic information currently used for estimating prognosis in stage II, node-positive breast cancer patients.

P100041

11/2/11

Edwards SAPIEN™ Transcatheter Heart Valve

Edwards Lifesciences, LLC

Irvine, CA

92614

Approval for the

SAPIEN™ Transcatheter Heart Valve, model 9000TFX, sizes 23mm and 26mm and accessories.

This device is indicated for transfemoral delivery in patients with severe symptomatic native

aortic valve stenosis who have been determined by a cardiac surgeon to be inoperable for open aortic valve replacement and in whom existing co-morbidities would not preclude the expected benefit from correction of the aortic stenosis.

P110010

11/22/11

PROMUS® Element™ Plus Everolimus-Eluting Platinum Chromium Coronary Stent

System (Monorail™ and Over-The-Wire)

Boston Scientific Corporation

Maple Grove, MN

55311

Approval for the PROMUS®

Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System. This device is indicated for improving luminal diameter in patients with symptomatic heart disease due to de novo lesions in native coronary arteries ≥ 2.25 mm to ≤ 4.00 mm in diameter in lesions ≤ 28 mm in

length.

P110019

11/1/11

XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System

Abbott Vascular, Inc.

Santa Clara, CA

95054

Approval for the XIENCE

PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System. This device is

indicated for improving coronary luminal diameter in patients with symptomatic heart disease due

to de novo native coronary artery lesions (length ≤ 32 mm) with reference vessel diameters of

≥ 2.25 mm to ≤ 4.25 mm.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P810002/S077 11/10/11 135-Day	St. Jude Mechanical Heart Valve	St. Jude Medical, Inc. St. Paul, MN 55117	Approval for eliminating the use of one method for coating thickness image capture and replace it with a new method.
P820003/S113 11/17/11 Real-Time	Various Families of Pasys, Spectrax, Symbios and Synergyst	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P830055/S106 11/2311 180-Day	LCS Total Knee System	DePuy Orthopaedics, Inc. Warsaw, IN 46581	Approval to manufacture the subject components from GUR 1020 polyethylene with an antioxidant (AOX™), to change the packaging components and materials, and to request approval of a shelf-life testing protocol for the subject P.F.C Sigma RP Curved and Stabilized Tibial Inserts.
P830061/S066 11/18/11 135-Day	CapSure, Vitatron Crystalline, and Vitatron Excellence PS+ Leads	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P840001/S184 11/9/11 135-Day	RestorePrime® Implantable Neurostimulator (INS), PrimeAdvanced® INS, Restore® INS, RestoreUltra® INS, RestoreAdvanced® INS and External Neurostimulator	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for a modification to a cleaning process for hybrid components.
P840001/S185 11/3/11 180-Day	RestoreSensor™ Rechargeable Implantable Neurostimulation System	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for the RestoreSensor™ Rechargeable Implantable Neurostimulation System. The device, as modified, will be marketed under the trade name RestoreSensor™ Rechargeable Implantable Neurostimulation System and is indicated for spinal cord stimulation (SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following conditions: 1) Failed Back Syndrome (FBS) or low back syndrome or failed back; 2) Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or herniated disk; 3) Postlaminectomy pain; 4) Multiple back operations; 5) Unsuccessful disk surgery; 6) Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and surgical interventions; 5) Peripheral causalgia; 6) Epidural fibrosis; 7) Arachnoiditis or lumbar adhesive arachnoiditis; and 8) Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia.
P850051/S078 11/17/11 Real-Time	Vitatron Legacy, Prevail, Premier and Various Families of Activitrax, Legend, Minix	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P850089/S078 11/18/11 135-Day	CapSure, CapSure Z Novus, Vitatron Excellence SS+ and Vitatron Impulse II Leads	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P860004/S150 11/9/11 135-Day	Synchromed® Pump	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for a modification to a cleaning process for hybrid components.
P860004/S159 11/10/11 Real-Time	SyncroMed II Implantable Infusion Pump	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for minor changes to the dimensional specifications of the SynchroMed II pump tube assembly component.
P890003/S181 11/9/11 180-day	Carelink Monitor, CardioSight® Reader, DDMA	Medtronic, Inc. Mounds View, MN 55112	Approval for the Protecta™ XT CRT-D, D314TRM and Protecta™ CRT-D D334TRM Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Protecta™ XT DR D314DRM and Protecta™ DR D334DRM Implantable Cardioverter Defibrillators, Model SW009 Application Software vl.0, Carelink Monitor Model 2490C upgrade, CardioSight Reader Model 2020A upgrade and Model 2491 DDMA upgrade.
P890003/S229 11/18/11 135-Day	CapSure, CapSure Model Leads	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P890003/S235 11/17/11 Real-Time	Prodigy, Minuet, Synergyst II and Various Families of Elite, Preva, Thera and Vitatron Legacy	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P890047/S022 11/3/11 180-Day	PROVISC® Ophthalmic Viscosurgical Device (OVD)	Alcon Research, Ltd. Fort Worth, TX 76134	Approval for an improved buffer formulation and latex-free packaging configuration for the device.
P900061/S110 11/17/11 Real-Time	Gem, PCD and Various Families of Jewel	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P910001/S040 11/18/11	Spectranetics Coronary Atherectomy (ELCA) Catheter	Spectranetics Corporation Colorado Springs, CO 80921	Approval for a sterilization site located at CaridianBCT Sterilization Services in Lakewood, Colorado.
P910023/S276 11/1/11 Real-Time	Promote and Unify Families of Pulse Generators	St. Jude Medical Sylmar, CA 91392	Approval for the introduction of the IS4/DF4 Port plug accessory model AC-IS4PP for use with all SJM DF4 or IS4 header ports.
P920015/S078 11/18/11 135-Day	Sprint Quattro, Subcutaneous Lead and Transvene SVC Leads	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P920023/S023 11/23/11 180-Day	UroLume® Endoprosthesis	American Medical Systems Minnetonka, MN 55343	Approval for modification of the device labeling to include the results of post approval studies.
P920047/S049 11/17/11 Real-Time	Blazer II, Blazer II HTD Cardiac Ablation Catheter	Boston Scientific Corporation San Jose, CA 95134	Approval for the internal glue flap and the carton end closure changes to the packaging design.
P930022/S013 11/17/11 Real-Time	Legend Plus	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P930039/S056 11/18/11 135-Day	CapSure, SureFix and Vitatron Crystalline ActFix Leads	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P940035/S006 11/15/11 180-Day	NMP22® BladderChek® Test Kit	Alere Scarborough, Inc. Scarborough, ME 04074	Approval for manufacturing site located at Alere Scarborough, Inc. in Scarborough, Maine.
P950009/S013 11/10/11 Real-Time	BD FocalPoint™ Slide Profiler	TRIPATH Imaging, Inc. Durham, NC 27703	Approval for software changes to the BD FocalPoint™ Slide Profiler from the current production version APPS 3.4.1a to APPS 3.5.0.
P960009/S115 11/9/11 135-Day	Activa® PC INS, Activa RC INS and External Neurostimulator	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for a modification to a cleaning process for hybrid components.
P960013/S066 11/1/11 180-Day	Tendril and Pacemaker Leads	St. Jude Medical Sylmar, CA 91342	Approval for three additional lead lengths of 65, 85 and 100 cm in the Tendril STS pacemaker leads.
P960040/S235 11/17/11 180-Day	INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD, TELIGEN	Boston Scientific Corporation St. Paul, MN 55112	Approval for INCEPTA, ENERGEN. PUNCTUA and TELIGEN ICD Models and the INCEPTA, ENERGEN. PUNCTUA and COGNIS CRT-D Models and PRM Software Application Model 2868 and Pulse Generator Software. The devices as modified will be marketed under the trade names INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS ICD and CRT-D Models and are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias or for patients with heart failure who receive stable optimal pharmacological therapy: Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms and Left Bundle Branch Block (LBBB) with QRS ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class 1) ischemic heart failure.
P960042/S023 11/18/11 180-Day	SLS II Laser Sheath	Spectranetics Corporation Colorado Springs, CO 80921	Approval for a sterilization site located at CaridianBCT Sterilization Services in Lakewood, Colorado.
P960058/S089 11/17/11 180-Day	Auria Harmony HiResolution Bionic Ear System Neptune, AquaMic and SoundWave 2.1	Advanced Bionics, LLC Sylmar, CA 91342	Approval for a new off-the-ear sound processor called Neptune and its associated accessories. The Neptune processor, when used with the new AquaMic headpiece, is waterproof. In addition, a new version of SoundWave Professional Software Suite (SoundWave 2.1) is included in the supplement.
P970004/S112 11/9/11 135-Day	InterStim® II INS	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for a modification to a cleaning process for hybrid components.
P970012/S089 11/17/11 Real-Time	Kappa 400 IPG	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P970051/S075 11/29/11 135-Day	Nucleus Cochlear Implant System	Cochlear Americas Centennial, CO 80111	Approval for a change in tolerance to the Feedthrough Comb Sintered Powder Injection Molding.
P970051/S087 11/4/11 Real-Time	Nucleus 24 Cochlear Implant System	Cochlear Americas Centennial, CO 80111	Approval to modify the layout of the non-hermetic region of the feedthrough assembly on the currently approved CI24RE implant of the device.
P980003/S031 11/17/11 Real-Time	Chilli II Cooled Ablation System & Sterile Cables	Boston Scientific Corporation San Jose, CA 95134	Approval for the internal glue flap and the carton end closure changes to the packaging design.
P980016/S218 11/9/11 180-Day	Protecta™ and Protecta™ DR Implantable Cardioverter Defibrillators Model SW009 Application Software vl.0 Systems	Medtronic, Inc. Mounds View, MN 55112	Approval for the Protecta™ XT CRT-D, D314TRM and Protecta™ CRT-D D334TRM Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Protecta™ XT DR D314DRM and Protecta™ DR D334DRM Implantable Cardioverter Defibrillators, Model SW009 Application Software vl.0, Carelink Monitor Model 2490C upgrade. CardioSight Reader Model 2020A upgrade and Model 2491 DDMA upgrade.
P980016/S305 11/10/11 135-Day	Maximo II, Protecta, Protecta XT, Secura, and Virtuoso II	Medtronic, Inc. Mounds View, MN 55112	Approval for addition of a cleaning process at the supplier.
P980016/S323 11/17/11 Real-Time	Entrust, Intrinsic, Marquis, Onyx, Secura and Various Families of Gem, Maximo, Protecta and Virtuoso	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P980035/S242 11/17/11 Real-Time	Adapta, Advisa, AT500, EnPulse, EnRhythm, Relia, Sensia, Sigma, Versa and Various Families of Kappa	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P980035/S244 11/1/11 Real-Time	Adapta, Versa, Sensia and Relia IPG Devices	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to Medtronic’s Adapta/ Versa/Sensia and Relia Implantable Pulse Generator (IPG) Application Software to correct the battery measurement lock-up condition.
P980035/S245 11/22/11 Real-Time	Advisa DR A4DR01 Implantable Pulse Generator	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the hybrid design and protection integrated circuits approved under the referenced PMA.
P980037/S038 11/2/11 180-Day	AngioJet® Rheolytic™ Thrombectomy System	MEDRAD Interventional /Possis Minneapolis, MN 55433	Approval for a change of the Angiojet Ultra System Console software to version V2.0.14.
P980050/S062 11/18/11 135-Day	Transvene CS/SVC Leads	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P980050/S067 11/17/11 Real-Time	Jewel AF, GEM III AT	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P990001/S096 11/17/11 Real-Time	Diva IPG Family, Dema IPG Family and Various C-Series and T-Series Devices	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P990012/S010 11/16/11 135-Day	Elecsys HBsAg Immunoassay	Roche Professional Diagnostics Indianapolis, IN 46250	Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P990012/S011 11/17/11 135-Day	Elecsys HBsAg Immunoassay	Roche Diagnostics Indianapolis, IN 46250	Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P000006/S027 11/16/11 Real-Time	Titan Inflatable Penile Prosthesis	Coloplast Corporation Minneapolis, MN 55411	Approval to implement a new mold for the One-Touch Release (OTR) Pump body and associated changes to several dimensional specifications.
P000008/S22 11/18/11 180-Day	LAP-BAND® Adjustable Gastric Banding System	Allergan Goleta, CA 93117	Approval of the post-approval study protocol.
P000014/S024 11/10/11 Real-Time	VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrator	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14646	Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.
P000018/S045 11/4/11 135-Day	Novoste Beta-Cath System	Best Vascular, Inc. Norcross, GA 30093	Approval for changing lubing suppliers.
P000021/S020 11/23/11 180-Day	Dimension Vista® 500 System	Siemens Healthcare Diagnostics, Inc. Newark, DE 19714	Approval for the Dimension Vista® TPSA Flex® reagent cartridge for use on the Dimension Vista® 500 System.
P000032/S037 11/3/11 180-Day	Her Option Cryoablation Therapy System	CooperSurgical, Inc. Trumbull, CT 06611	Approval for manufacturing sites located at CooperSurgical, Inc. in Trumbull, Connecticut and Lone Star Medical Products in Stafford, Texas.
P000041/S010 11/8/11 180-Day	OnGuard 5.2.1	Riverain Medical Miamisburg, OH 45342	Approval for the OnGuard 5.2.1 computer aided detection software.
P000044/S028 11/10/11 Real-Time	VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator HBsAg Confirmatory Kit	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14646	Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.
P010012/S255 11/17/11 180-Day	INCEPTA CRT-D, ENERGEN CRT-D, PUNCTUA CRT-D, COGNIS	Boston Scientific Corporation St. Paul, MN 55112	Approval for INCEPTA, ENERGEN. PUNCTUA and TELIGEN ICD Models and the INCEPTA, ENERGEN. PUNCTUA and COGNIS CRT-D Models and PRM Software Application Model 2868 and Pulse Generator Software. The devices as modified will be marketed under the trade names INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS ICD and CRT-D Models and are indicated to provide ventricular antitachycardia pacing (ATP) and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias or for patients with heart failure who receive stable optimal pharmacological therapy: Moderate to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms and Left Bundle Branch Block (LBBB) with QRS ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class I) ischemic heart failure.
P010015/S129 11/18/11 135-Day	Attain Leads	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P010015/S139 11/17/11 Real-Time	Consulta CRT-P, Syncra CRT-P, InSync/InSync III	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P010019/S025 11/2/11 180-Day	AIR OPTIX® NIGHT & DAY® AQUA (lotrafilcon A) soft contact lenses	CIBA VISION Corporation Duluth, GA 30097	Approval for a trade name change to the spherical (lotrafilcon A) soft contact lenses with wetting agent (l % Copolymer 845) in package saline, and the addition of descriptive text for symbols appearing on the cartons, except the Rx symbol used for "prescription use," as well as the trade name changes to all the lotrafilcon A lens designs. The device, as modified, will be marketed under the following trade names: Spherical – AIR OPTIX® NIGHT & DAY® AQUA; Toric – AIR OPTIX® NIGHT & DAY® AQUA ASTIGMATISM; Multifocal – AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL; and Multifocal Toric – AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL TORIC and is indicated for the following: AIR OPTIXC® NIGHT & DAY® AQUA (lotrafilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 1.50 diopters or less of astigmatism. AIR OPTIX® NIGHT & DAY® AQUA for ASTIGMATISM (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic persons with non-diseased eyes who have 6.00 diopters (D) or less of astigmatism. AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +4.00 diopters (D) or less and who have 1.50 diopters or less of astigmatism. AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL TORIC (lotrafilcon A) soft contact lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia, astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and have 6.00 diopters (D) or less of astigmatism. The lenses may be prescribed for daily wear or extended wear for up to 30 nights continuous wear with removal for disposal, or cleaning and disinfection (chemical not heat) prior to reinsertion, as recommended by the eye care professional. Lotrafilcon A contact lenses are also indicated for therapeutic use. Use as a bandage to protect the corneal and to relieve corneal pain in the treatment of acute or chronic ocular pathologies, such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies as well as post-surgical conditions resulting from cataract extraction and corneal surgery. Lotrafilcon A soft contact lenses for therapeutic use can also provide optical correction during healing if required.
P010021/S021 11/10/11 Real-Time	VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14646	Approval for change in on-instrument storage of patient samples from 2 hours to 3 hours.
P010031/S178 11/9/11 180-Day	Protecta™ XT CRT-D, and Protecta™ CRT-D Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Model SW009 Application Software vl.0 Systems	Medtronic, Inc. Mounds View, MN 55112	Approval for the Protecta™ XT CRT-D, D314TRM and Protecta™ CRT-D D334TRM Implantable Cardioverter Defibrillators with Cardiac Rcsynchronization, Protecta™ XT DR D314DRM and Protecta™ DR D334DRM Implantable Cardioverter Defibrillators, Model SW009 Application Software vl.0, Carelink Monitor Model 2490C upgrade. CardioSight Reader Model 2020A upgrade and Model 2491 DDMA upgrade.
P010031/S259 11/11/11 135-Day	Concerto II, Consulta, Maximo II, Protecta and Protecta XT	Medtronic, Inc. Mounds View, MN 55112	Approval for addition of a cleaning process at the supplier.
P010031/S277 11/17/11 Real-Time	Consulta CRT-D Maximo II CRT-D and Various Families of Concerto, InSync and Protecta	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P010032/S039 11/2/11 135-Day	Genesis Line Neurostimulation IPG Systems	St. Jude Medical Plano, TX 75024	Approval to add an electronic switch supplier for the device.
P010054/S016 11/17/11 135-Day	Elecsys Anti-HBs Immunoassay	Roche Diagnostics Indianapolis, IN 46250	Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P020001/S009 11/18/11 Real-Time	STAN® S31 Fetal Heart Monitor	Neoventa Medical AB Moeindal, Sweden SE-431 35	Approval for the addition of an accessory, the STAN Viewer Live, which allows remote viewing of an ongoing STAN S31 recording.
P020004/S062 11/10/11 180-Day	GORE® EXCLUDER® AAA Endoprosthesis	W. L. Gore & Associated, Inc. Flagstaff, AZ 86003	Approval for a manufacturing site located in Phoenix, Arizona.
P020004/S064 11/17/11 Real-Time	GORE® EXCLUDER® AAA Endoprosthesis	W. L. Gore & Associated, Inc. Flagstaff, AZ 86003	Approval for the addition of the 23 and 27 mm Contralateral Leg Component and several minor labeling changes.
P020025/S031 11/17/11 Real-Time	Maestro 3000 Cardiac Ablation System	Boston Scientific Corporation San Jose, CA 95134	Approval for the internal glue flap and the carton end closure changes to the packaging design.
P020027/S015 11/23/11 180-Day	Dimension Vista® 500 System	Siemens Healthcare Diagnostics, Inc. Newark, DE 19714	Approval for the Dimension Vista® FPSA Flex® reagent cartridge for use on the Dimension Vista® 500 System.
P020050/S006 11/23/11 180-Day	WaveLight® EX500 Laser System	Alcon Laboratories, Inc. Fort Worth, TX 76134	Approval for increased pulse frequency from 400 to 500 Hz, a new laser head, a new housing with greater integration of accessories, modified laser pulse temporal parameters, new eyetracker, new scanner, remodeled user interface, addition of networking capability, and modified software. The device, as modified, will be marketed under the trade name WaveLight® EX500 Laser System and is indicated for laser assisted in situ keratomileusis (LASIK) for: 1) the reduction or elimination of myopia of up to -12.0 diopters (D) of sphere and up to – 6.0 D of astigmatism at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery; 2) the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D in patients who are 18 years of age or older with documentation of stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia; 3) the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane in patients who are 21 years of age or older with documentation of a stable manifest refraction defined as ≤ 0.50 D preoperative spherical equivalent shift over one year prior to surgery; and 4) the wavefront-guided (WFG) reduction or elimination of up to -7.00 D of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical shift over one year prior to surgery.
P030008/S006 11/23/11 180-Day	WaveLight® EX500 Laser System	Alcon Laboratories, Inc. Fort Worth, TX 76134	Approval for increased pulse frequency from 400 to 500 Hz, a new laser head, a new housing with greater integration of accessories, modified laser pulse temporal parameters, new eyetracker, new scanner, remodeled user interface, addition of networking capability, and modified software. The device, as modified, will be marketed under the trade name WaveLight® EX500 Laser System and is indicated for laser assisted in situ keratomileusis (LASIK) for: 1) the reduction or elimination of myopia of up to -12.0 diopters (D) of sphere and up to – 6.0 D of astigmatism at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery; 2) the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D in patients who are 18 years of age or older with documentation of stable manifest refraction defined as ≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery, exclusive of changes due to unmasking latent hyperopia; 3) the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at the spectacle plane in patients who are 21 years of age or older with documentation of a stable manifest refraction defined as ≤ 0.50 D preoperative spherical equivalent shift over one year prior to surgery; and 4) the wavefront-guided (WFG) reduction or elimination of up to -7.00 D of spherical equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical component and up to 3.00 D of astigmatic component at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical shift over one year prior to surgery.
P030024/S017 11/10/11 Real-Time	VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14646	Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.
P030026/S024 11/10/11 Real-Time	VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator	Ortho-Clinical Diagnostics, Inc. Rochester, NY 14646	Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.
P030028/S001 11/9/11 180-Day	Verisyse™ Phakic Intraocular Lens (PIOL)	Ophtec Ev Boca Raton, FL 33487	Approval of the post-approval study protocol.
P030036/S032 11/18/11 135-Day	SelectSecure Leads	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P030054/S173 11/29/11 180-Day	Promote Q CRT-D, Promote Quadra CRT-D, Unify Quadra CRT-D, Quartet LV Lead and Model 3330 version 12.1.1 Programmer Software	St. Jude Medical Sunnyvale, CA 94086	Approval for Promote Q Model CD3221-36 CRT-D, Promote Quadra Models CD 3245-40/40Q CRT-D, Unify Quadra CRT-D Models CD3249-40/40Q CRT-D, Quartet Model 1458Q LV Lead, and Model 3330 version 12.1.1 Programmer Software.
P030054/S202 11/1/11 Real-Time	Fortify and Current Families of CRT-Ds	St. Jude Medical Sylmar, CA 91392	Approval for the introduction of the IS4/DF4 Port plug accessory model AC-IS4PP for use with all SJM DF4 or IS4 header ports.
P040027/S024 11/10/11 180-Day	Gore VIATORR TIPS Endoprosthesis	W. L. Gore & Associates, Inc. Flagstaff, AZ 86003	Approval for a manufacturing site located in Phoenix, Arizona.
P040048/S015 11/4/11 180-Day	Trilogy AB Acetabular System	Zimmer, Inc. Warsaw, IN 46581	Approval of the Post-approval study protocol.
P050023/S047 11/17/11 180-Day	Lumax 500/540	Biotronik, Inc. Lake Oswego, OR 97035	Approval for the addition of the Thoracic Impedance (TI) measurement feature to the currently approved Lumax 500/540 Implantable Cardioverter Defibrillators and Cardiac Resynchronization Defibrillator devices.
P050049/S008 11/14/11 135-Day	Abbott AxSYM HBsAg	Abbott Laboratories Abbott Park, IL 60064	Approval for a change to a supplier for an incoming raw material, nonfat dry milk (NFDM) that is a component of the AxSYM HBsAg Conjugate Diluent in the AxSYM HBsAg Reagent Pack in the AxSYM HBsAg assay.
P060011/S002 11/22/11 Real-Time	C-flex™ Aspheric Intraocular Lens	Rayner Intraocular Lenses Limited Laguna Beach, CA 92651	Approval for the addition of an aspheric optical surface to the anterior surface of the parent C-flex™ Aspheric Intraocular Lens Model 570C, as well as the addition of a Modulation Transfer Function (MTF) figure to the Physician’s Labeling comparing both models (i.e., 970C and 570C).
P060039/S021 11/22/11 180-Day	Medtronic Attain Starfix Lead	Medtronic, Inc. Mounds View, MN 55112	Approval for a change in the requirement for the copper content in the blue polyurethane tubing utilized by the Medtronic Attain StarFix™ lead from 200 ppm to 300 ppm.
P060039/S026 11/18/11 135-Day	Attain StarFix Leads	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P070006/S007 11/23/11 Real-Time	T-SPOT.TB Test	Oxford Immunotec, Ltd. Oxfordshire, England OX144RY	Approval for the addition of a new test kit format with increased reagent volumes and 50 antibody coated 96-well microtitre plates to increase the kit capacity to a total of 1200 tests.
P070014/S027 11/17/11 Real-Time	LifeStent Solo Vascular Stent System	Bard Peripheral Vascular, Inc. Tempe, AZ 85281	Approval for a smaller packaging configuration and minor labeling changes to accommodate the changes to the packaging.
P070022/S024 11/23/11 Real-Time	Adiana Permanent Contraception System	Hologic, Inc. Marlborough, MA 01752	Approval for a change to the Adiana catheter to increase the flexibility for use with hysteroscopes with articulating tips.
P080006/S029 11/18/11 135-Day	Attain Ability Leads	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P080007/S007 11/16/11 Real-Time	LifeStar Vascular Stent System	Bard Peripheral Vascular, Inc. Tempe, AZ 85281	Approval for removal of the PerforMaXX grip on the delivery system, the addition of a smaller packaging configuration, and minor labeling changes. The device, as modified, will be marketed under the trade name LifeStar Vascular Stent System and is indicated for the treatment of iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries up to 126 mm in length with a reference vessel diameter of 5 to 9 mm.
P080025/S004 11/9/11 135-Day	InterStim® II INS	Medtronic Neuromodulation Minneapolis, MN 55432	Approval for a modification to a cleaning process for hybrid components.
P080026/S002 11/30/11 135-Day	Abbott RealTime HBV Assay	Abbott Molecular, Inc. Des Plaines, IL 60018	Approval for a raw material change for two of the microvials used to manufacture the reagent components in the Abbott RealTime HBV Amplification kit within the Abbott RealTime HBV Assay.
P090002/S001 11/4/11 180-Day	Pinnacle CoMplete Acetabular System	DePuy Orthopaedics, Inc. Warsaw, IN 46581	Approval of the post-approval study protocol.
P090007/S004 11/16/11 135-Day	Elecsys Anti-HCV Immunoassay on cobas e 411	Roche Professional Diagnostics Indianapolis, IN 46250	Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P090007/S005 11/17/11 135-Day	Elecsys Anti-HCV Immunoassay on cobas e 411	Roche Diagnostics Indianapolis, IN 46250	Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P090008/S004 11/16/11 135-Day	Elecsys Anti-HCV Immunoassay on cobas e 601	Roche Professional Diagnostics Indianapolis, IN 46250	Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P090008/S005 11/17/11 135-Day	Elecsys Anti-HCV Immunoassay on cobas e 601	Roche Diagnostics Indianapolis, IN 46250	Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P090009/S004 11/16/11 135-Day	Elecsys Anti-HCV Immunoassay on MODULAR ANALYTICS E170	Roche Professional Diagnostics Indianapolis, IN 46250	Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P090009/S005 11/17/11 135-Day	Elecsys Anti-HCV Immunoassay on MODULAR ANALYTICS E170	Roche Diagnostics Indianapolis, IN 46250	Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P090013/S028 11/18/11 135-Day	CapSure Fix	Medtronic, Inc. Mounds View, MN 55112	Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.
P090013/S040 11/17/11 Real-Time	Revo MRI	Medtronic, Inc. Mounds View, MN 55112	Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.
P090022/S009 11/16/11 135-Day	Softec HD, Softec I and Softec HD PS Intraocular Lenses	Lenstec, Inc. Saint Petersburg, FL 33716	Approval for the way in which a test reagent is incubated.
P100017/S001 11/30/11 135-Day	Abbott RealTime HCV Assay	Abbott Molecular, Inc. Des Plaines, IL 60018	Approval for a raw material change for two of the microvials used to manufacture the reagent components in the Abbott RealTime HCV Amplification kit within the Abbott RealTime HCV Assay.
P100031/S002 11/16/11 135-Day	Elecsys Anti-HBc Immunoassay on MODULAR ANALYTICS E170	Roche Professional Diagnostics Indianapolis, IN 46250	Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P100031/S004 11/17/11 135-Day	Elecsys Anti-HBc Immunoassay on MODULAR ANALYTICS E170	Roche Diagnostics Indianapolis, IN 46250	Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.
P100032/S002 11/16/11 135-Day	Elecsys Anti-HBc Immunoassay on Elecsys 2010	Roche Professional Diagnostics Indianapolis, IN 46250	Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).
P100032/S004 11/17/11 135-Day	Elecsys Anti-HBc Immunoassay on Elecsys 2010	Roche Diagnostics Indianapolis, IN 46250	Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.

APPLICATION NUMBER / DATE of APPROVAL

DEVICE TRADE NAME

COMPANY NAME CITY, STATE, & ZIP

DEVICE DESCRIPTION / INDICATIONS

P810002/S077

11/10/11

135-Day

St. Jude Mechanical Heart Valve

St. Jude Medical, Inc.

St. Paul, MN

55117

Approval for eliminating the use of one method for coating thickness image capture and replace it with a new method.

P820003/S113

11/17/11

Real-Time

Various Families of Pasys, Spectrax, Symbios and Synergyst

Medtronic, Inc.

Mounds View, MN

55112

Approval for an update to the operating system software for the CareLink Programmer associated with Medtronic pacemaker, implantable cardioverter defibrillator (ICD), and cardiac resynchronization therapy (CRT) devices approved under the referenced PMA.

P830055/S106

11/2311

180-Day

LCS Total Knee System

DePuy Orthopaedics, Inc. Warsaw, IN

46581

Approval to manufacture the subject components from GUR 1020 polyethylene with an antioxidant (AOX™), to change the packaging components and materials, and to request approval of a shelf-life testing protocol for the subject P.F.C Sigma RP Curved and Stabilized Tibial Inserts.

P830061/S066

11/18/11

135-Day

CapSure, Vitatron Crystalline, and Vitatron Excellence PS+ Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P840001/S184

11/9/11

135-Day

RestorePrime® Implantable Neurostimulator (INS), PrimeAdvanced® INS, Restore® INS, RestoreUltra® INS, RestoreAdvanced® INS and External Neurostimulator

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for a modification to a cleaning process for hybrid components.

P840001/S185

11/3/11

180-Day

RestoreSensor™ Rechargeable Implantable Neurostimulation System

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for the RestoreSensor™ Rechargeable Implantable Neurostimulation

System. The device, as modified, will be marketed under the trade name RestoreSensor™

Rechargeable Implantable Neurostimulation System and is indicated for spinal cord stimulation

(SCS) as an aid in the management of chronic, intractable pain of the trunk and/or limbs including unilateral or bilateral pain associated with the following conditions:

1) Failed Back Syndrome (FBS) or low back syndrome or failed back;

2) Radicular pain syndrome or radiculopathies resulting in pain secondary to FBS or

herniated disk;

3) Postlaminectomy pain; 4) Multiple back operations;

5) Unsuccessful disk surgery;

6) Degenerative Disk Disease (DDD)/herniated disk pain refractory to conservative and

surgical interventions;

5) Peripheral causalgia;

6) Epidural fibrosis;

7) Arachnoiditis or lumbar adhesive arachnoiditis; and

8) Complex Regional Pain Syndrome (CRPS), Reflex Sympathetic Dystrophy (RSD), or causalgia.

P850051/S078

11/17/11

Real-Time

Vitatron Legacy, Prevail, Premier and Various Families of Activitrax, Legend, Minix

Medtronic, Inc.

Mounds View, MN

55112

P850089/S078

11/18/11

135-Day

CapSure, CapSure Z Novus, Vitatron Excellence SS+ and Vitatron Impulse II Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P860004/S150

11/9/11

135-Day

Synchromed® Pump

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for a modification to a cleaning process for hybrid components.

P860004/S159

11/10/11

Real-Time

SyncroMed II Implantable Infusion Pump

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for minor changes to the dimensional specifications of the SynchroMed II pump tube assembly component.

P890003/S181

11/9/11

180-day

Carelink Monitor,

CardioSight® Reader, DDMA

Medtronic, Inc.

Mounds View, MN

55112

Approval for the Protecta™ XT CRT-D, D314TRM and Protecta™ CRT-D

D334TRM Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Protecta™

XT DR D314DRM and Protecta™ DR D334DRM Implantable Cardioverter Defibrillators,

Model SW009 Application Software vl.0, Carelink Monitor Model 2490C upgrade, CardioSight

Reader Model 2020A upgrade and Model 2491 DDMA upgrade.

P890003/S229

11/18/11

135-Day

CapSure, CapSure Model Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P890003/S235

11/17/11

Real-Time

Prodigy, Minuet, Synergyst II and Various Families of Elite, Preva, Thera and Vitatron Legacy

Medtronic, Inc.

Mounds View, MN

55112

P890047/S022

11/3/11

180-Day

PROVISC® Ophthalmic Viscosurgical Device (OVD)

Alcon Research, Ltd.

Fort Worth, TX

76134

Approval for an improved buffer formulation and latex-free packaging configuration for the device.

P900061/S110

11/17/11

Real-Time

Gem, PCD and Various Families of Jewel

Medtronic, Inc.

Mounds View, MN

55112

P910001/S040

11/18/11

Spectranetics Coronary Atherectomy (ELCA) Catheter

Spectranetics Corporation

Colorado Springs, CO

80921

Approval for a sterilization site located at CaridianBCT Sterilization Services in Lakewood, Colorado.

P910023/S276

11/1/11

Real-Time

Promote and Unify Families of Pulse Generators

St. Jude Medical

Sylmar, CA

91392

Approval for the introduction of the IS4/DF4 Port plug accessory model AC-IS4PP for use with all SJM DF4 or IS4 header ports.

P920015/S078

11/18/11

135-Day

Sprint Quattro, Subcutaneous Lead and Transvene SVC Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P920023/S023

11/23/11

180-Day

UroLume® Endoprosthesis

American Medical Systems

Minnetonka, MN

55343

Approval for modification of the device labeling to include the results of post approval studies.

P920047/S049

11/17/11

Real-Time

Blazer II, Blazer II HTD Cardiac Ablation Catheter

Boston Scientific Corporation

San Jose, CA

95134

Approval for the internal glue flap and the carton end closure changes to the packaging design.

P930022/S013

11/17/11

Real-Time

Legend Plus

Medtronic, Inc.

Mounds View, MN

55112

P930039/S056

11/18/11

135-Day

CapSure, SureFix and Vitatron Crystalline ActFix Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P940035/S006

11/15/11

180-Day

NMP22® BladderChek® Test Kit

Alere Scarborough, Inc.

Scarborough, ME

04074

Approval for manufacturing site located at Alere Scarborough, Inc. in Scarborough, Maine.

P950009/S013

11/10/11

Real-Time

BD FocalPoint™ Slide Profiler

TRIPATH Imaging, Inc.

Durham, NC

27703

Approval for software changes to the BD FocalPoint™ Slide Profiler from the current production version APPS 3.4.1a to APPS 3.5.0.

P960009/S115

11/9/11

135-Day

Activa® PC INS, Activa RC INS and External Neurostimulator

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for a modification to a cleaning process for hybrid components.

P960013/S066

11/1/11

180-Day

Tendril and Pacemaker Leads

St. Jude Medical

Sylmar, CA

91342

Approval for three additional lead lengths of 65, 85 and 100 cm in the Tendril STS pacemaker leads.

P960040/S235

11/17/11

180-Day

INCEPTA ICD, ENERGEN ICD, PUNCTUA ICD, TELIGEN

Boston Scientific Corporation

St. Paul, MN

55112

Approval for INCEPTA, ENERGEN. PUNCTUA and TELIGEN ICD Models and the INCEPTA, ENERGEN. PUNCTUA and COGNIS CRT-D Models and PRM Software

Application Model 2868 and Pulse Generator Software. The devices as modified will be

marketed under the trade names INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS

ICD and CRT-D Models and are indicated to provide ventricular antitachycardia pacing (ATP)

and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

or for patients with heart failure who receive stable optimal pharmacological therapy: Moderate

to severe heart failure (NYHA Class III-IV) with EF ≤ 35% and QRS duration ≥ 120 ms and Left Bundle Branch Block (LBBB) with QRS ≥ 130 ms, EF ≤ 30%, and mild (NYHA Class II) ischemic or nonischemic heart failure or asymptomatic (NYHA Class 1) ischemic heart failure.

P960042/S023

11/18/11

180-Day

SLS II Laser Sheath

Spectranetics Corporation

Colorado Springs, CO

80921

Approval for a sterilization site located at CaridianBCT Sterilization Services in Lakewood, Colorado.

P960058/S089

11/17/11

180-Day

Auria Harmony HiResolution Bionic Ear System Neptune, AquaMic and SoundWave 2.1

Advanced Bionics, LLC

Sylmar, CA

91342

Approval for a new off-the-ear sound processor called Neptune and its associated accessories. The Neptune processor, when used with the new AquaMic headpiece, is waterproof. In addition, a new version of SoundWave Professional Software Suite (SoundWave 2.1) is included in the supplement.

P970004/S112

11/9/11

135-Day

InterStim® II INS

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for a modification to a cleaning process for hybrid components.

P970012/S089

11/17/11

Real-Time

Kappa 400 IPG

Medtronic, Inc.

Mounds View, MN

55112

P970051/S075

11/29/11

135-Day

Nucleus Cochlear Implant System

Cochlear Americas

Centennial, CO

80111

Approval for a change in tolerance to the Feedthrough Comb Sintered Powder Injection Molding.

P970051/S087

11/4/11

Real-Time

Nucleus 24 Cochlear Implant System

Cochlear Americas

Centennial, CO

80111

Approval to modify the layout of the non-hermetic region of the feedthrough assembly on the currently approved CI24RE implant of the device.

P980003/S031

11/17/11

Real-Time

Chilli II Cooled Ablation System & Sterile Cables

Boston Scientific Corporation

San Jose, CA

95134

Approval for the internal glue flap and the carton end closure changes to the packaging design.

P980016/S218

11/9/11

180-Day

Protecta™ and Protecta™ DR

Implantable Cardioverter Defibrillators

Model SW009 Application Software vl.0 Systems

Medtronic, Inc.

Mounds View, MN

55112

Approval for the Protecta™ XT CRT-D, D314TRM and Protecta™ CRT-D

D334TRM Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Protecta™

XT DR D314DRM and Protecta™ DR D334DRM Implantable Cardioverter Defibrillators,

Model SW009 Application Software vl.0, Carelink Monitor Model 2490C upgrade. CardioSight

Reader Model 2020A upgrade and Model 2491 DDMA upgrade.

P980016/S305

11/10/11

135-Day

Maximo II, Protecta, Protecta XT, Secura, and Virtuoso II

Medtronic, Inc.

Mounds View, MN

55112

Approval for addition of a cleaning process at the supplier.

P980016/S323

11/17/11

Real-Time

Entrust, Intrinsic, Marquis, Onyx, Secura and Various Families of Gem, Maximo, Protecta and Virtuoso

Medtronic, Inc.

Mounds View, MN

55112

P980035/S242

11/17/11

Real-Time

Adapta, Advisa, AT500, EnPulse, EnRhythm, Relia, Sensia, Sigma, Versa and Various Families of Kappa

Medtronic, Inc.

Mounds View, MN

55112

P980035/S244

11/1/11

Real-Time

Adapta, Versa, Sensia and Relia IPG Devices

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to Medtronic’s Adapta/ Versa/Sensia and Relia Implantable Pulse Generator (IPG) Application Software to correct the battery measurement lock-up condition.

P980035/S245

11/22/11

Real-Time

Advisa DR A4DR01 Implantable Pulse Generator

Medtronic, Inc.

Mounds View, MN

55112

Approval for an update to the hybrid design and protection integrated circuits approved under the referenced PMA.

P980037/S038

11/2/11

180-Day

AngioJet® Rheolytic™ Thrombectomy System

MEDRAD Interventional /Possis

Minneapolis, MN

55433

Approval for a change of the Angiojet Ultra System Console software to version V2.0.14.

P980050/S062

11/18/11

135-Day

Transvene CS/SVC Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P980050/S067

11/17/11

Real-Time

Jewel AF, GEM III AT

Medtronic, Inc.

Mounds View, MN

55112

P990001/S096

11/17/11

Real-Time

Diva IPG Family, Dema IPG Family and Various C-Series and T-Series Devices

Medtronic, Inc.

Mounds View, MN

55112

P990012/S010

11/16/11

135-Day

Elecsys HBsAg Immunoassay

Roche Professional Diagnostics

Indianapolis, IN

46250

Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).

P990012/S011

11/17/11

135-Day

Elecsys HBsAg Immunoassay

Roche Diagnostics

Indianapolis, IN

46250

Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.

P000006/S027

11/16/11

Real-Time

Titan Inflatable Penile Prosthesis

Coloplast Corporation

Minneapolis, MN

55411

Approval to implement a new mold for the One-Touch Release (OTR) Pump body and associated changes to several dimensional specifications.

P000008/S22

11/18/11

180-Day

LAP-BAND® Adjustable Gastric Banding System

Allergan

Goleta, CA

93117

Approval of the post-approval study protocol.

P000014/S024

11/10/11

Real-Time

VITROS Immunodiagnostic Products Anti-HBs Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14646

Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.

P000018/S045

11/4/11

135-Day

Novoste Beta-Cath System

Best Vascular, Inc.

Norcross, GA

30093

Approval for changing lubing suppliers.

P000021/S020

11/23/11

180-Day

Dimension Vista® 500 System

Siemens Healthcare Diagnostics, Inc.

Newark, DE

19714

Approval for the Dimension Vista® TPSA Flex® reagent cartridge for use on the Dimension Vista® 500 System.

P000032/S037

11/3/11

180-Day

Her Option Cryoablation Therapy System

CooperSurgical, Inc.

Trumbull, CT

06611

Approval for manufacturing sites located at CooperSurgical, Inc. in Trumbull, Connecticut and Lone Star Medical Products in Stafford, Texas.

P000041/S010

11/8/11

180-Day

OnGuard 5.2.1

Riverain Medical

Miamisburg, OH

45342

Approval for the OnGuard 5.2.1 computer aided detection software.

P000044/S028

11/10/11

Real-Time

VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator HBsAg Confirmatory Kit

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14646

Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.

P010012/S255

11/17/11

180-Day

INCEPTA CRT-D, ENERGEN CRT-D, PUNCTUA CRT-D, COGNIS

Boston Scientific Corporation

St. Paul, MN

55112

Approval for INCEPTA, ENERGEN. PUNCTUA and TELIGEN ICD Models and the INCEPTA, ENERGEN. PUNCTUA and COGNIS CRT-D Models and PRM Software

Application Model 2868 and Pulse Generator Software. The devices as modified will be

marketed under the trade names INCEPTA, ENERGEN, PUNCTUA, TELIGEN AND COGNIS

ICD and CRT-D Models and are indicated to provide ventricular antitachycardia pacing (ATP)

and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias

or for patients with heart failure who receive stable optimal pharmacological therapy: Moderate

P010015/S129

11/18/11

135-Day

Attain Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P010015/S139

11/17/11

Real-Time

Consulta CRT-P, Syncra CRT-P, InSync/InSync III

Medtronic, Inc.

Mounds View, MN

55112

P010019/S025

11/2/11

180-Day

AIR OPTIX® NIGHT & DAY® AQUA (lotrafilcon A) soft contact lenses

CIBA VISION Corporation

Duluth, GA

30097

Approval for a trade name change to the spherical (lotrafilcon A) soft contact lenses with wetting agent (l % Copolymer 845) in package saline, and the addition of descriptive text for symbols appearing on the cartons, except the Rx

symbol used for "prescription use," as well as the trade name changes to all the lotrafilcon A lens designs. The device, as modified, will be marketed under the following trade names: Spherical – AIR OPTIX® NIGHT & DAY® AQUA; Toric – AIR OPTIX® NIGHT & DAY® AQUA ASTIGMATISM; Multifocal – AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL; and Multifocal Toric – AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL TORIC and is indicated for the following:

AIR OPTIXC® NIGHT & DAY® AQUA (lotrafilcon A) spherical soft contact lenses are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic or aphakic

persons with non-diseased eyes who have 1.50 diopters or less of astigmatism.

AIR OPTIX® NIGHT & DAY® AQUA for ASTIGMATISM (lotrafilcon A) soft contact lenses

are indicated for the optical correction of refractive ametropia (myopia and hyperopia) in phakic

or aphakic persons with non-diseased eyes who have 6.00 diopters (D) or less of astigmatism.

AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL (lotrafilcon A) soft contact lenses are

indicated for the optical correction of refractive ametropia (myopia and hyperopia) and/or

presbyopia in phakic or aphakic persons with non-diseased eyes who may require a reading

addition of +4.00 diopters (D) or less and who have 1.50 diopters or less of astigmatism.

AIR OPTIX® NIGHT & DAY® AQUA MULTIFOCAL TORIC (lotrafilcon A) soft contact

lenses are indicated for the optical correction of refractive ametropia (myopia, hyperopia,

astigmatism and presbyopia) in phakic or aphakic persons with non-diseased eyes who may require a reading addition of +3.00 diopters (D) or less and have 6.00 diopters (D) or less of astigmatism.

The lenses may be prescribed for daily wear or extended wear for up to 30 nights continuous wear with removal for disposal, or cleaning and disinfection (chemical not heat) prior to reinsertion, as recommended by the eye care professional.

Lotrafilcon A contact lenses are also indicated for therapeutic use. Use as a bandage to protect the corneal and to relieve corneal pain in the treatment of acute or chronic ocular pathologies,

such as bullous keratopathy, corneal erosions, entropion, corneal edema, and corneal dystrophies

as well as post-surgical conditions resulting from cataract extraction and corneal surgery.

Lotrafilcon A soft contact lenses for therapeutic use can also provide optical correction during

healing if required.

P010021/S021

11/10/11

Real-Time

VITROS Immunodiagnostic Products Anti-HCV Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14646

Approval for change in on-instrument storage of patient samples from 2 hours to 3 hours.

P010031/S178

11/9/11

180-Day

Protecta™ XT CRT-D, and Protecta™ CRT-D

Implantable Cardioverter Defibrillators with Cardiac Resynchronization,

Model SW009 Application Software vl.0 Systems

Medtronic, Inc.

Mounds View, MN

55112

Approval for the Protecta™ XT CRT-D, D314TRM and Protecta™ CRT-D

D334TRM Implantable Cardioverter Defibrillators with Cardiac Rcsynchronization, Protecta™

XT DR D314DRM and Protecta™ DR D334DRM Implantable Cardioverter Defibrillators,

Model SW009 Application Software vl.0, Carelink Monitor Model 2490C upgrade. CardioSight

Reader Model 2020A upgrade and Model 2491 DDMA upgrade.

P010031/S259

11/11/11

135-Day

Concerto II, Consulta, Maximo II, Protecta and Protecta XT

Medtronic, Inc.

Mounds View, MN

55112

Approval for addition of a cleaning process at the supplier.

P010031/S277

11/17/11

Real-Time

Consulta CRT-D Maximo II CRT-D and Various Families of Concerto, InSync and Protecta

Medtronic, Inc.

Mounds View, MN

55112

P010032/S039

11/2/11

135-Day

Genesis Line Neurostimulation IPG Systems

St. Jude Medical

Plano, TX

75024

Approval to add an electronic switch supplier for the device.

P010054/S016

11/17/11

135-Day

Elecsys Anti-HBs Immunoassay

Roche Diagnostics

Indianapolis, IN

46250

Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.

P020001/S009

11/18/11

Real-Time

STAN® S31 Fetal Heart Monitor

Neoventa Medical AB

Moeindal, Sweden

SE-431 35

Approval for the addition of an accessory, the STAN Viewer Live, which allows remote viewing of an ongoing STAN S31 recording.

P020004/S062

11/10/11

180-Day

GORE® EXCLUDER® AAA Endoprosthesis

W. L. Gore & Associated, Inc.

Flagstaff, AZ

86003

Approval for a manufacturing site located in Phoenix, Arizona.

P020004/S064

11/17/11

Real-Time

GORE® EXCLUDER® AAA Endoprosthesis

W. L. Gore & Associated, Inc.

Flagstaff, AZ

86003

Approval for the addition of the 23 and 27 mm Contralateral Leg Component and several minor labeling changes.

P020025/S031

11/17/11

Real-Time

Maestro 3000 Cardiac Ablation System

Boston Scientific Corporation

San Jose, CA

95134

Approval for the internal glue flap and the carton end closure changes to the packaging design.

P020027/S015

11/23/11

180-Day

Dimension Vista® 500 System

Siemens Healthcare Diagnostics, Inc.

Newark, DE

19714

Approval for the Dimension Vista® FPSA Flex® reagent cartridge for use on the Dimension Vista® 500 System.

P020050/S006

11/23/11

180-Day

WaveLight® EX500 Laser System

Alcon Laboratories, Inc.

Fort Worth, TX

76134

Approval for increased pulse frequency from 400 to 500 Hz, a new laser head, a

new housing with greater integration of accessories, modified laser pulse temporal parameters,

new eyetracker, new scanner, remodeled user interface, addition of networking capability, and

modified software. The device, as modified, will be marketed under the trade name WaveLight®

EX500 Laser System and is indicated for laser assisted in situ keratomileusis (LASIK) for:

1) the reduction or elimination of myopia of up to

-12.0 diopters (D) of sphere and up to

– 6.0 D of astigmatism at the spectacle plane in patients who are 18 years of age or older

with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative

spherical equivalent shift over one year prior to surgery;

2) the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with

and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D in patients who

are 18 years of age or older with documentation of stable manifest refraction defined as

≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery,

exclusive of changes due to unmasking latent hyperopia;

3) the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at

the spectacle plane in patients who are 21 years of age or older with documentation of a

stable manifest refraction defined as ≤ 0.50 D preoperative spherical equivalent shift over one year prior to surgery; and 4) the wavefront-guided (WFG) reduction or elimination of up to -7.00 D of spherical

equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical

component and up to 3.00 D of astigmatic component at the spectacle plane in patients who are 18 years of age or older with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative spherical shift over one year prior to surgery.

P030008/S006

11/23/11

180-Day

WaveLight® EX500 Laser System

Alcon Laboratories, Inc.

Fort Worth, TX

76134

Approval for increased pulse frequency from 400 to 500 Hz, a new laser head, a

new housing with greater integration of accessories, modified laser pulse temporal parameters,

new eyetracker, new scanner, remodeled user interface, addition of networking capability, and

modified software. The device, as modified, will be marketed under the trade name WaveLight®

EX500 Laser System and is indicated for laser assisted in situ keratomileusis (LASIK) for:

1) the reduction or elimination of myopia of up to

-12.0 diopters (D) of sphere and up to

– 6.0 D of astigmatism at the spectacle plane in patients who are 18 years of age or older

with documentation of a stable manifest refraction defined as ≤ 0.50 D of preoperative

spherical equivalent shift over one year prior to surgery;

2) the reduction or elimination of hyperopic refractive errors up to +6.0 D of sphere with

and without astigmatic refractive errors up to 5.0 D at the spectacle plane, with a maximum manifest refraction spherical equivalent (MRSE) of +6.0 D in patients who

are 18 years of age or older with documentation of stable manifest refraction defined as

≤ 0.50 D of preoperative spherical equivalent shift over one year prior to surgery,

exclusive of changes due to unmasking latent hyperopia;

3) the reduction or elimination of naturally occurring mixed astigmatism of up to 6.00 D at

the spectacle plane in patients who are 21 years of age or older with documentation of a

equivalent myopia or myopia with astigmatism, with up to -7.00 D of spherical

P030024/S017

11/10/11

Real-Time

VITROS Immunodiagnostic Products Anti-HBc Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14646

Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.

P030026/S024

11/10/11

Real-Time

VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator

Ortho-Clinical Diagnostics, Inc.

Rochester, NY

14646

Approval for the change in on-instrument storage of patient samples from 2 hours to 3 hours.

P030028/S001

11/9/11

180-Day

Verisyse™ Phakic Intraocular Lens (PIOL)

Ophtec Ev

Boca Raton, FL

33487

Approval of the post-approval study protocol.

P030036/S032

11/18/11

135-Day

SelectSecure Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P030054/S173

11/29/11

180-Day

Promote Q CRT-D,

Promote Quadra CRT-D, Unify Quadra CRT-D, Quartet LV Lead and Model 3330 version 12.1.1 Programmer Software

St. Jude Medical

Sunnyvale, CA

94086

Approval for Promote Q Model CD3221-36 CRT-D, Promote Quadra Models CD 3245-40/40Q CRT-D, Unify Quadra CRT-D Models CD3249-40/40Q CRT-D, Quartet Model 1458Q LV Lead, and Model 3330 version 12.1.1 Programmer Software.

P030054/S202

11/1/11

Real-Time

Fortify and Current Families of CRT-Ds

St. Jude Medical

Sylmar, CA

91392

Approval for the introduction of the IS4/DF4 Port plug accessory model AC-IS4PP for use with all SJM DF4 or IS4 header ports.

P040027/S024

11/10/11

180-Day

Gore VIATORR TIPS Endoprosthesis

W. L. Gore & Associates, Inc.

Flagstaff, AZ

86003

Approval for a manufacturing site located in Phoenix, Arizona.

P040048/S015

11/4/11

180-Day

Trilogy AB Acetabular System

Zimmer, Inc.

Warsaw, IN

46581

Approval of the Post-approval study protocol.

P050023/S047

11/17/11

180-Day

Lumax 500/540

Biotronik, Inc.

Lake Oswego, OR

97035

Approval for the addition of the Thoracic Impedance (TI) measurement feature to the currently approved Lumax 500/540 Implantable Cardioverter Defibrillators and Cardiac Resynchronization Defibrillator devices.

P050049/S008

11/14/11

135-Day

Abbott AxSYM HBsAg

Abbott Laboratories

Abbott Park, IL

60064

Approval for a change to a supplier for an incoming raw material, nonfat dry milk (NFDM) that is a component of the AxSYM HBsAg Conjugate Diluent in the AxSYM HBsAg Reagent Pack in the AxSYM HBsAg assay.

P060011/S002

11/22/11

Real-Time

C-flex™ Aspheric Intraocular Lens

Rayner Intraocular Lenses Limited

Laguna Beach, CA

92651

Approval for the addition of an aspheric optical surface to the anterior surface of the parent C-flex™ Aspheric Intraocular Lens Model 570C, as well as the addition of a Modulation Transfer Function (MTF) figure to the Physician’s Labeling comparing both models (i.e., 970C and 570C).

P060039/S021

11/22/11

180-Day

Medtronic Attain Starfix Lead

Medtronic, Inc.

Mounds View, MN

55112

Approval for a change in the requirement for the copper content in the blue polyurethane tubing utilized by the Medtronic Attain StarFix™ lead from 200 ppm to 300 ppm.

P060039/S026

11/18/11

135-Day

Attain StarFix Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P070006/S007

11/23/11

Real-Time

T-SPOT.TB Test

Oxford Immunotec, Ltd.

Oxfordshire, England

OX144RY

Approval for the addition of a new test kit format with increased reagent volumes and 50 antibody coated 96-well microtitre plates to increase the kit capacity to a total of 1200 tests.

P070014/S027

11/17/11

Real-Time

LifeStent Solo Vascular Stent System

Bard Peripheral Vascular, Inc.

Tempe, AZ

85281

Approval for a smaller packaging configuration and minor labeling changes to accommodate the changes to the packaging.

P070022/S024

11/23/11

Real-Time

Adiana Permanent Contraception System

Hologic, Inc.

Marlborough, MA

01752

Approval for a change to the Adiana catheter to increase the flexibility for use with hysteroscopes with articulating tips.

P080006/S029

11/18/11

135-Day

Attain Ability Leads

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P080007/S007

11/16/11

Real-Time

LifeStar Vascular Stent System

Bard Peripheral Vascular, Inc.

Tempe, AZ

85281

Approval for removal of the PerforMaXX grip on the delivery system, the addition of a smaller packaging configuration, and minor labeling changes. The device, as

modified, will be marketed under the trade name LifeStar Vascular Stent System and is indicated

for the treatment of iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries up to

126 mm in length with a reference vessel diameter of

5 to 9 mm.

P080025/S004

11/9/11

135-Day

InterStim® II INS

Medtronic Neuromodulation

Minneapolis, MN

55432

Approval for a modification to a cleaning process for hybrid components.

P080026/S002

11/30/11

135-Day

Abbott RealTime HBV Assay

Abbott Molecular, Inc.

Des Plaines, IL

60018

Approval for a raw material change for two of the microvials used to manufacture the reagent components in the Abbott RealTime HBV Amplification kit within the Abbott RealTime HBV Assay.

P090002/S001

11/4/11

180-Day

Pinnacle CoMplete Acetabular System

DePuy Orthopaedics, Inc.

Warsaw, IN

46581

Approval of the post-approval study protocol.

P090007/S004

11/16/11

135-Day

Elecsys Anti-HCV Immunoassay on cobas e 411

Roche Professional Diagnostics

Indianapolis, IN

46250

Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).

P090007/S005

11/17/11

135-Day

Elecsys Anti-HCV Immunoassay on cobas e 411

Roche Diagnostics

Indianapolis, IN

46250

Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.

P090008/S004

11/16/11

135-Day

Elecsys Anti-HCV Immunoassay on cobas e 601

Roche Professional Diagnostics

Indianapolis, IN

46250

Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).

P090008/S005

11/17/11

135-Day

Elecsys Anti-HCV Immunoassay on cobas e 601

Roche Diagnostics

Indianapolis, IN

46250

Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.

P090009/S004

11/16/11

135-Day

Elecsys Anti-HCV Immunoassay on MODULAR ANALYTICS E170

Roche Professional Diagnostics

Indianapolis, IN

46250

Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).

P090009/S005

11/17/11

135-Day

Elecsys Anti-HCV Immunoassay on MODULAR ANALYTICS E170

Roche Diagnostics

Indianapolis, IN

46250

Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.

P090013/S028

11/18/11

135-Day

CapSure Fix

Medtronic, Inc.

Mounds View, MN

55112

Approval for updates to the sterile packaging assembly process for new and existing sealer equipment.

P090013/S040

11/17/11

Real-Time

Revo MRI

Medtronic, Inc.

Mounds View, MN

55112

P090022/S009

11/16/11

135-Day

Softec HD, Softec I and Softec HD PS Intraocular Lenses

Lenstec, Inc.

Saint Petersburg, FL

33716

Approval for the way in which a test reagent is incubated.

P100017/S001

11/30/11

135-Day

Abbott RealTime HCV Assay

Abbott Molecular, Inc.

Des Plaines, IL

60018

Approval for a raw material change for two of the microvials used to manufacture the reagent components in the Abbott RealTime HCV Amplification kit within the Abbott RealTime HCV Assay.

P100031/S002

11/16/11

135-Day

Elecsys Anti-HBc Immunoassay on MODULAR ANALYTICS E170

Roche Professional Diagnostics

Indianapolis, IN

46250

Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).

P100031/S004

11/17/11

135-Day

Elecsys Anti-HBc Immunoassay on MODULAR ANALYTICS E170

Roche Diagnostics

Indianapolis, IN

46250

Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.

P100032/S002

11/16/11

135-Day

Elecsys Anti-HBc Immunoassay on Elecsys 2010

Roche Professional Diagnostics

Indianapolis, IN

46250

Approval for the in-process test method for determination of particle concentration of Elecsys coated microparticle (beads).

P100032/S004

11/17/11

135-Day

Elecsys Anti-HBc Immunoassay on Elecsys 2010

Roche Diagnostics

Indianapolis, IN

46250

Approval for changes to the manufacturing procedure for the bead coating process of the intermediate storage form of Elecys coated microparticles.

30-Day Notices (135 Day Supplement was not required)

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P810031/S041 11/3/11	Sodium Hyaluronate Ophthalmic Viscolastic Devices (OVD), Healon, Healon GV and Healon5 Ophthalmic Viscosurgical Devices	Abbott Medical Optics, Inc. Santa Ana, CA 92705	Change in the Anti- Blocking additive in the Blister trays.
P820033/S008 11/2/11	Plasmaflo OP-05W(A)	Asahi Kasei Kuraray Medical Company, Ltd. Tokyo, Japan 101-8101	Moving the Plasmaflo manufacturing equipment to a new facility located within the current manufacturing site.
P840001/S197 11/10/10	Restore Family of Implantable Neurostimulators	Medtronic, Inc. Minneapolis, MN 55432	Update data entry during the wafer test process from a manual to an automated process.
P850007/S032 11/2/11	Physio-Stim, Spinal-Stim and Cervical-Stim	Orthofix, Inc. Lewisville, TX 75056	Addition of an alternate battery pack supplier.
P850079/S051 11/29/11	Frequency 55, Frequency 58 UV. Frequency XCEL, Expression Colors, Expression Accents, Hydrasoft (methafilcon A and methafilcon B) Soft (Hydrophilic) Contact Lens	CooperVision, Inc. Pleasanton, CA 94588	Change in the stability of shelf life protocol.
P860004/S160 11/10/11	SynchroMed Family of Infusion Systems	Medtronic, Inc. Minneapolis, MN 55432	Update data entry during the wafer test process from a manual to an automated process.
P890023/S018 11/29/11	Biomedics 55 (ocufilcon D) Soft (Hydrophilic) Contact Lenses	CooperVision, Inc. Pleasanton, CA 94588	Change in the stability shelf life protocol.
P900060/S047 11/29/11	Carbomedics Prosthetic Heart Valve (CPHV)	Sorin Group USA, Inc. Arvada, CO 80004	Alternate carbon coating process for CPHV sewing cuff manufacturing.
P910023/S277 11/23/11	Cadence/Current/ Promote Family of ICDs	St. Jude Medical Sylmar, CA 91342	Addition of a device level test within the current suite of automated manufacturing tests.
P910023/S278 11/23/11	Cadence Family of ICDs	St. Jude Medical Sylmar, CA 91342	Alternate automated inspection method for verification of connector seal integrity.
P910073/S099 11/18/11	RELIANCE 4-SITE IS-4 Leads	Boston Scientific Corporation St. Paul, MN 55112	Change to the setup position in a seal test.
P930016/S036 11/17/11	STAR Excimer Laser and WaveScan WaveFront System	AMO Manufacturing USA, LLC Milpitas, CA 95035	Addition of a new capacitor and a replacement microscope tube.
P930029/S034 11/14/11	RF Contactr, RF Conductr, RF Marinr, RF Marinr 5Fr and RF Enhancer II Families of Ablation Catheters	Medtronic, Inc. Mounds View, MN 55112	Addition of an alternate supplier for various components.
P930038/S069 11/15/11	Angio-Seal Evolution Vascular Closure Device	St. Jude Medical, Inc. St. Paul, MN 55117	Alternate method for ensuring stent deployment specification requirements.
P950029/S064 11/23/11	Reply SR/DR and Esprit SR/DR IPGs	Sorin CRM USA, Inc. Plymouth, MN 55441	Implementation of alternate manufacturing equipment.
P950032/S065 11/22/11	Apligraf	Organogenesis, Inc. Canton, MA 02021	Implementation of an alternate vendor.
P960009/S128 11/3/11	Model 37085 Extension	Medtronic Neuromodulation Minneapolis, MN 55432	Addition of a quality test to the manufacturing process.
P960009/S129 11/3/11	Soletra Implantable	Medtronic Neuromodulation Minneapolis, MN 55432	Change to the cleaning process.
P960009/S130 11/10/11	Activa Family of Implantable Neurostimulators	Medtronic, Inc. Minneapolis, MN 55432	Reduction in sample size for incoming visual inspection of medical adhesive tubes.
P960009/S131 11/10/11	Activa Family of Implantable Neurostimulators	Medtronic, Inc. Minneapolis, MN 55432	Update data entry during the wafer test process from a manual to an automated process.
P960043/S076 11/23/11	Perclose Proglide Suture Medicated Closure System	Abbott Vascular, Inc. Redwood City, CA 94063	Replacement of ancillary Overmolding Press equipment.
P970003/S139 11/9/11	VNS Therapy® System	Cyberonics, Inc. Houston, TX 77058	Change to the welding parameters for the VNS pulse generators.
P980003/S032 11/10/11	Chilli II Catheter System	Boston Scientific Corporation San Jose, CA 95134	Change in supplier for sterile connector cables.
P980016/S324 11/2/11	Maximo II, Protecta, Protecta XT, Secura, Virtuoso II	Medtronic, Inc. Mounds View, MN 55112	Automate data entry during wafer testing.
P980016/S326 11/30/11	Maximo II, Protecta, Protecta XT, Secura and Virtuoso II	Medtronic, Inc. Mounds View, MN 55112	Removal of rejection criteria and associated re-clean process for flux bleed-out on RF modules.
P980035/S246 11/2/11	Adapta, Advisa, EnRhythm, Relia, Sensia, Versa	Medtronic, Inc. Mounds View, MN 55112	Automate data entry during wafer testing.
P980035/S247 11/23/11	350 Series, EnRhythm and Sigma IPGs	Medtronic, Inc. Mounds View, MN 55112	Consolidation of manufacturing operations and related equipment changes at a supplier’s location.
P980035/S248 11/23/11	Advisa	Medtronic, Inc. Mounds View, MN 55112	Updates to a final functional test application.
P980049/S066 11/30/11	Paradym VR & DR ICDs	Sorin CRM Plymouth, MN 55441	Use of an alternate reflow oven with an updated reflow soldering profile and an alternate component carrier.
P990001/S098 11/23/11	Vitatron DA+ C-Series and Vitatron DA+ T-Series IPGs	Medtronic, Inc. Mounds View, MN 55112	Consolidation of manufacturing operations and related equipment changes at a supplier’s location.
P990038/S014 11/15/11	ETI-MAK-2 PLUS Kit	DiaSorin, Inc. Stillwater, MN 55082	Second vendor of Chromogen/ Substrate bulk solution.
P990041/S013 11/15/11	ETI-AB-EBK PLUS Kit	DiaSorin, Inc. Stillwater, MN 55082	Second vendor of Chromogen/ Substrate bulk solution.
P990042/S010 11/15/11	ETI-AB-AUK PLUS Kit	DiaSorin, Inc. Stillwater, MN 55082	Second vendor of Chromogen/ Substrate bulk solution.
P990044/S011 11/15/11	ETI-CORE-IGMK Plus Kit	DiaSorin, Inc. Stillwater, MN 55082	Second vendor of Chromogen/ Substrate bulk solution.
P990045/S011 11/15/11	ETI-AB-COREK PLUS Kit	DiaSorin, Inc. Stillwater, MN 55082	Second vendor of Chromogen/ Substrate bulk solution.
P990046/S025 11/15/11	Open Pivot Heart Valve	Medtronic, Inc. Minneapolis, MN 55432	Additional supplier of device component subassemblies.
P010015/S141 11/2/11	Consulta CRT-P, Syncra CRT-P	Medtronic, Inc. Mounds View, MN 55112	Automate data entry during wafer testing.
P010015/S143 11/23/11	InSync III CRT-D	Medtronic, Inc. Mounds View, MN 55112	Consolidation of manufacturing operations and related equipment changes at a supplier’s location.
P010015/S144 11/23/11	Consulta CRT-P, Syncra CRT-P	Medtronic, Inc. Mounds View, MN 55112	Updates to a final functional test application.
P010031/S278 11/2/11	Concerto II, Consulta, Maximo II, Protecta, Protecta XT	Medtronic, Inc. Mounds View, MN 55112	Automate data entry during wafer testing.
P010031/S279 11/30/11	Concerto II, Consulta, Maximo II, Protecta, Protecta XT	Medtronic, Inc. Mounds View, MN 55112	Removal of rejection criteria and associated re-clean process for flux bleed-out on RF modules.
P010032/S043 11/3/11	Genesis Line Neurostimulation (IPG) Systems	St. Jude Medical Plano, TX 75024	Implement a new pouch sealer to seal all terminally sterilized pouches.
P010047/S014 11/10/11	ProGel™ Pleural Air Leak Sealant	Neomend, Inc. Irvine, CA 92618	Modifications in an inspection process.
P030034/S006 11/2/11	Physio-Stim, Spinal-Stim and Cervical-Stim	Orthofix, Inc. Lewisville, TX 75056	Addition of an alternate battery pack supplier.
P030054/S204 11/23/11	Epic HF/Atlas HF/ Unity/Fortify Family of CRT-Ds	St. Jude Medical Sylmar, CA 91342	Addition of a device level test within the current suite of automated manufacturing tests.
P030054/S205 11/23/11	Epic HF/Atlas+ HF Family of CRT-Ds	St. Jude Medical Sylmar, CA 91342	Alternate automated inspection method for verification of connector seal integrity.
P040002/S034 11/4/11	Endoluminal Prosthesis	Endologix, Inc. Irvine, CA 92618	Inclusion of an additional storage facility.
P040014/S018 11/10/11	Therapy Cardiac Ablation System	St. Jude Medical Irvine, CA 92614	Addition of an additional vendor to assemble printed circuit boards.
P040037/S039 11/23/11	GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface	W.L. Gore & Associates, Inc. Flagstaff, AZ 86001	Software update for a trimming system.
P040042/S023 11/10/11	Therapy Dual 8 Cardiac Ablation System	St. Jude Medical Irvine, CA 92614	Addition of an additional vendor to assemble printed circuit boards.
P050006/S025 11/4/11	Gore Helex Septal Occluder	W.L. Gore & Associates Flagstaff, AZ 86001	Replacement of equipment for measuring fiber diameter.
P050016/S008 11/10/11	Cormet Hip Resurfacing System	Corin U.S.A. Tampa, FL 33612	Modification to the type of manufacturing process for the device.
P050045/S003 11/10/11	TOP2 FISH pharmDx™ Kit	Dako Denmark A/S Glostrup, Denmark DK-2600	Add an alternate supplier of Texas Red labeled dCTP nucleotide and to replace an in-process QC procedure with a new QC test on FFPE breast cancer tissue.
P060002/S022 11/17/11	Bard FLAIR Endovascular Stent Graft	C.R. Bard, Inc. Tempe, AZ 85281	Addition of a new system to monitor environmental controls.
P060019/S019 11/10/11	Therapy Cool Path Ablation Catheter and IBI RF Ablation Generator	St. Jude Medical Irvine, CA 92614	Addition of an additional vendor to assemble printed circuit boards.
P060027/S033 11/30/11	Paradym CRT-Ds	Sorin CRM Plymouth, MN 55441	Use of an alternate reflow oven with an updated reflow soldering profile and an alternate component carrier.
P070014/S029 11/17/11	LifeStent Vascular Stent Systems	C.R. Bard, Inc. Tempe, AZ 85281	Addition of a new system to monitor environmental controls.
P070015/S083 11/15/11	XIENCE V, XIENCE nano, and PROMUS Everolimus-Eluting Coronary Stents	Abbott Vascular, Inc. Temecula, CA 92591	Reduction in the frequency of monitoring a manufacturing process temperature.
P080007/S009 11/17/11	E-LUMINEXX Vascular Stent	C.R. Bard, Inc. Tempe, AZ 85281	Addition of a new system to monitor environmental controls.
P080011/S006 11/29/11	Biofinity (comfilcon A) Soft (Hydrophilic) Contact Lens	CooperVision, Inc. Pleasanton, CA 94588	Change in the stability shelf life protocol.
P090013/S041 11/2/11	Revo MRI	Medtronic, Inc. Mounds View, MN 55112	Automate data entry during wafer testing.
P090013/S043 11/23/11	Revo MRI IPG	Medtronic, Inc. Mounds View, MN 55112	Consolidation of manufacturing operations and related equipment changes at a supplier’s location.

Summary of PMA Originals & Supplements Approved

Originals: 6

Supplements: 106

Summary of PMA Originals Under Review

Total Under Review: 81

Total Active: 33

Total On Hold: 48

Number Greater Than 180 Days: 3

Summary of PMA Supplements Under Review

Total Under Review: 599

Total Active: 473

Total On Hold: 126

Number Greater Than 180 Days: 10

Summary of All PMA Submissions Received

Originals: 1

Supplements: 88

Summary of PMA Supplement PMA Approval/Denial Decision Times

Number of Approvals: 106

Number of Denials: 0

Average Days Fr Receipt to Decision (Total Time): 177

FDA Time: 133.5 Days MFR Time: 43.5 Days

FDA releases November PMA approvals

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