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.

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.

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

RSS From Medical Design & Outsourcing

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  • Safety alert: Recall on two IV solutions from Baxter
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