Summary of PMA Originals Under Review 
Total Under Review: 55                                                         
Total Active: 22                                                                      
Total On Hold: 33                                                                                          

Summary of PMA Supplements Under Review 
Total Under Review: 655                                                       
Total Active: 481                                            
Total On Hold: 174        

Summary of All PMA Submissions Received
Originals: 8                                                                  
Supplements: 81                                                                     

Summary of PMA Supplement PMA Approval/Denial Decision Times 
Number of Approvals: 72                                                       
Number of Denials: 0                                                  
Average Days Fr Receipt to Decision (Total Time): 127.9       
FDA Time: 99.5 Days      MFR Time: 28.4 Days

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P080009 5/3/13	SEDASYS® Computer-Assisted Personalized Sedation System	Ethicon Endo-Surgery, Incorporated Cincinnati, OH  45242	Approval for the SEDASYS® Computer-Assisted Personalized Sedation System. This device is indicated for the intravenous administration of 1% (10 mg/mL) propofol injectable emulsion for the initiation and maintenance of minimal to moderate sedation, as defined by the American Society of Anesthesiologists (ASA) Continuum of Depth of Sedation, in ASA physical status I and II patients ≥ 18 years old undergoing colonoscopy and esophagogastroduod-denoscopy (EGD) procedures.
P120014 5/29/13	THxID™ BRAF Kit for use on the ABI 7500 Fast Dx Real-Time PCR Instrument	bioMerieux, Inc. Hazelwood, MO 63042	Approval for the THxID™ BRAF Kit for use on the ABI 7500 Fast Dx Real-Time PCR Instrument. This device is indicated for: The THxIDTM BRAF kit is an In Vitro Diagnostic device intended for the qualitative detection of the BRAF V600E and V600K mutations in DNA samples extracted from formalin-fixed paraffinembedded (FFPE) human melanoma tissue. The THxID™ BRAF kit is a real-time PCR test on the ABI 7500 Fast Dx system and is intended to be used as an aid in selecting melanoma patients whose tumors carry the BRAF V600E mutation for treatment with dabrafenib [Tafinlar®] and as an aid in selecting melanoma patients whose tumors carry the BRAF V600E or V600K mutation for treatment with trametinib [Mekinist™].
P120019 5/14/13	cobas® EGFR Mutation Test	Roche Molecular Systems, Inc. Pleasanton, CA  94588	Approval for the cobas® EGFR Mutation Test. The cobas® EGFR Mutation Test is a real-time PCR test for the qualitative detection of exon 19 deletions and exon 21 (L858R) substitution mutations of the epidermal growth factor receptor (EGFR) gene in DNA derived from formalin-fixed paraffin-embedded (FFPET) human non-small cell lung cancer (NSCLC) tumor tissue. The test is intended to be used as an aid in selecting patients with metastatic NSCLC for whom Tarceva® (erlotinib), an EGFR tyrosine kinase inhibitor (TK1), is indicated. Specimens are processed using the cobas® DNA Sample Preparation Kit for manual sample preparation and the cobas z 480 analyzer for automated amplification and detection.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL	DEVICE TRADE NAME	COMPANY NAME CITY, STATE, & ZIP	DEVICE DESCRIPTION / INDICATIONS
P820003/S117 5/30/13 180-Day	Versatrax Pacing System	Medtronic, Inc.  Mounds View, MN 55112	Approval for the implementation of a DF-4 lead compatible, crimpable alligator clip onto the Surgical Cables, process improvements for the splice yoke of the cables and a change to the wire gauges used in the 2292 cable assembly.
P850064/S021 5/16/13 180-Day	LifePulse High Frequency Ventilator	Bunnell, Incorporated Salt Lake City, UT 84115	Approval for a change in the insulation material on the raw heater wire in the patient circuit.
P860003/S068 5/1/13 180-Day	THERAKOS® CELLEX® Photopheresis System	THERAKOS, Inc.  Raritan, NJ  08869	Approval for software changes to the THERAKOS® CELLEX® Photopheresis System (software Version 4.1).
P860004/S191 5/23/13 Special	Medtronic SynchroMed Infusion System	Medtronic Neuromodulation Minneapolis, MN 55432	Approval of labeling changes for device refill kit Model 8551 to accommodate the possibility for the use of multiple syringes during kit refill procedures.
P890003/S265 5/30/13 180-Day	Synergyst II Pacing System	Medtronic, Inc.  Mounds View, MN 55112	Approval for the implementation of a DF-4 lead compatible, crimpable alligator clip onto the Surgical Cables, process improvements for the splice yoke of the cables and a change to the wire gauges used in the 2292 cable assembly.
P890003/S269 5/24/13 180-Day	MyCareLink Patient Monitor and Accessories	Medtronic, Inc. Moundsview, MN 55112	Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P910056/S014 5/15/13 135-Day	enVista Intraocular Lens	Bausch & Lomb, Inc. Aliso Viejo, CA 92656	Addition of an alternate packaging component supplier for the enVista Intraocular Lens Model MX60 vial package.
P910073/S116 5/7/13 Real-Time	Endotak Lead System	Boston Scientific  St. Paul, MN  55112	Approval for an alternate primer material for the FLEXTEND and Active Fixation Reliance IS-1/4-SITE leads.
P950037/S121 5/8/13 Real-Time	Philos DR-T, Philos II DR-T, Cylos  DR-T, Evia DR-T/ Evia SR-T, Entovis DR-T/Entovis SR-T, Estella DR-T/ Estella SR-T	Biotronik, Inc. Lake Oswego, OR 97035	Approval for an updated Version 3.22.0 of Home Monitoring Service Center including the features: 1) Implementation of Remote Scheduling; and 2) Automatic export of EHR data.
P960006/S038 5/7/13 Real-Time	FLEXTEND Leads	Boston Scientific  St. Paul, MN  55112	Approval for an alternate primer material for the FLEXTEND and Active Fixation Reliance IS-1/4-SITE leads.
P960058/S098 5/20/13 180-Day	HiResolution Bionic Ear System  HiFocus™ Mid-Scala Electrode for HiRes 90K™ Advantage Cochlear Implant	Advanced Bionics,  Sylmar, CA  91342	Approval for an alternate electrode configuration for the HiRes 90K™ Advantage Cochlear Implant device, the "Hi Focus™ Mid-Scala Electrode.”
P970003/S158 5/2/13 Real-Time	VNS Therapy System	Cyberonics, Inc. Houston, TX,  77058	Approval for a new torque wrench model featuring a “recessed nose” design.
P970029/S024 5/31/13 Real-Time	TMR2000 Holmium Laser System	Cardiogenesis, Inc. Kennesaw, GA 30144	Approval for design changes to the distal fibers of the three hand-piece models. The device, as modified, will be marketed under the trade name TMR2000 Holmium Laser System and is indicated for trans-myocardial revascularization in patients with angina refractory to medical treatment and secondary to objectively demonstrated coronary artery atherosclerosis and with a region of the myocardium with reversible ischemia not amenable to direct coronary revascularization.
P970051/S091 5/28/13 180-Day	Nucleus Cochlear Implant System – Aqua Accessory for the Nucleus 5 (CP810) Sound Processor	Cochlear Americas  Centennial, CO 80111	Approval for the Aqua Accessory for the Nucleus Cochlear Implant System. The Aqua Accessory is a water resistant pouch that is sealable at one end, and holds the external Nucleus 5 CP810 sound processor and coil. It may be used for up to an hour to keep the external components dry during use in water (e.g., swimming). The Aqua Accessory is intended for unilateral or bilateral use by cochlear implant recipients who have the ability to notify a caregiver or the ability to remove the device on their own, if the device becomes hot or if there is a change in sound quality.
P980016/S400 5/24/13 180-Day	EnTrust ICD; Intrinsic 30 ICD; Intrinsic ICD; Marquis DR ICD; Marquis VR ICD; Maximo DR ICD; Maximo VR ICD	Medtronic, Inc. Moundsview, MN 55112	Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P980023/S052 5/8/13 Real-Time	Belos VR-T	Biotronik, Inc. Lake Oswego, OR 97035	Approval for an updated Version 3.22.0 of Home Monitoring Service Center including the features: 1) Implementation of Remote Scheduling; and 2) Automatic export of EHR data.
P980035/S311 5/24/13 180-Day	Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG; EnPulse E1 IPG; EnPulse E2 IPG; EnRhythm IPG; Kappa D (Kappa 700) IPG; Kappa D (Kappa 900) IPG; Kappa DR (Kappa 650) IPG; Kappa DR (Kappa 700/600) IPG; Kappa DR (Kappa 900/800) IPG; Kappa SR (Kappa 700) IPG; Kappa SR (Kappa 900) IPG; Kappa VDD (Kappa 700) IPG	Medtronic, Inc. Moundsview, MN 55112	Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P980035/S317 5/15/13  Real-Time	Advisa DR MRI IPG	Medtronic, Inc. Moundsview, MN 55112	Approval for two minor design changes to the L310 Integrated Circuit for the Advisa DR MRI device.
P980049/S071 5/9/13 180-Day	Paradym RF VR Model 9250 and DR Model 9550	Sorin CRM USA, Inc. Plymouth, MN 55441	Approval for the Smartview Home Monitor. The device, as modified, will be marketed under the trade name Smartview Home Monitor and is indicated for use with Sorin radio frequency implanted cardiac device only and any household traditional (analog type) telephone land line; It will not operate with other lines such as and not limited to digital, DSL or optical for the PSTN device and the SMARTVIEW monitor is designed for use with the Sorin radio frequency implanted cardiac device only for GPRS devices.
P990012/S016 5/14/13 135-Day	Elecsys® HBsAg Immunoassay, Elecsys® PreciControl HBsAg, and Elecsys® HBsAg Confirmatory Test	Roche Diagnostics Corporation Indianapolis, IN 46250	Approval for a change to the specifications for the negative human serum incoming material.
P990027/S018 5/17/13 180-Day	TECHNOLAS® 217z Zyoptix System	Technolas® Perfect Vision, Gmbh  Lutz, FL 33558	Approval for the addition of the advanced Planoscan software to be used with the device.
P000006/S033 5/31/13 Real-Time	Titan Inflatable Penile Prosthesis	Coloplast Corporation  Minneapolis MN 55411	Approval for modifications to the deflation button and valve of the pump component, and related changes to the labeling to reflect these modifications.
P000009/S054 5/8/13 Real-Time	Belos DR-T, Belos A+-T, Lexos DR-T/ Lexos VR-T, Xelos DR-T, Lumos  DR-T/Lumos VR-T	Biotronik, Inc. Lake Oswego, OR 97035	Approval for an updated Version 3.22.0 of Home Monitoring Service Center including the features: 1) Implementation of Remote Scheduling; and 2) Automatic export of EHR data.
P000025/S068 5/16/13 Real-Time	MED-EL COMBI 40+ Cochlear Implant System and  MED-EL Reusable Mi1000 PIN Drill Guide	MED-EL Corporation  Durham, NC  27713	Approval for the reusable Mi1000 PIN Drill Guide which assists in the surgical implantation of the approved Mi1000 CONCERT PIN implant.
P000029/S074 5/22/13 Special	Deflux® Injectable Gel	Salix Pharmaceuticals, Inc.  Raleigh, NC  27615	Approval for update to the information for post-approval adverse reactions and update on the labeling of the sponsor name and contact information.
P000040/S027 5/16/13 180-Day	Genesys HT A System ProCerva Procedure Set	Boston Scientific Corporation Marlborough, MA 01752	Approval for a manufacturing sites located at Boston Scientific Corporation, in Spencer, Indiana, and Boston Scientific Corporation, in Coventry, Rhode Island.
P000054/S039 5/31/13 Special	INFUSE™ Bone Graft	Medtronic Sofamor Danek USA, Inc.  Memphis, TN  38132	Approval for modifications to the package insert to reflect the results of Study 400.
P010015/S190 5/24/13 180-Day	Consulta and Syncra CRT-P	Medtronic, Inc. Moundsview, MN 55112	Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P010031/S363 5/24/13 180-Day	InSync III Marquis, InSync Marquis, InSync Maximo,  Insync II Protect	Medtronic, Inc. Moundsview, MN 55112	Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P010032/S061 5/8/13 135-Day	Genesis Pulse Generator, 8-Channel Neurostimulation System, GenesisXP Pulse Generator, 8-Channel Neurostimulation System, Genesis Pulse Generator, Dual4 Channel Neurostimulation System, GenesisXP Pulse Generator, Dual4 Channel Neurostimulation System, GenesisRC Pulse Generator Neurostimulation System, GenesisRC Pulse Generator, Dual4 Channel Neurostimulation System	St. Jude Medical Plano, Texas  75024	Approval to eliminate the use of liquid no-clean solder flux and to change the solid flux core wire used in the soldering process.
P010032/S068 5/17/13 Real-Time	Eon Mini Implantable Pulse Generators (IPG) Neurostimulation System	St. Jude Medical Plano, TX  75024	Approval for changes to the Eon Mini Implantable Pulse Generator (IPG) model 3788 software.
P010059/S004 5/23/13 180-Day	Capsular Tension Rings and Pre-loaded EYEJECT Injectors with Capsular Tension Rings	Morcher GmbH  Centerville, MA 02632	Approval for the expansion of your family of capsular tension rings (CTRs) available pre-loaded on the EYEJET injector to include new CTR models Type 10G, 10L, 15, 15A, and 15B. In addition, you requested approval to supply currently approved CTR Type 10C as pre-loaded on the EYEJET injector.
P020018/S048 5/9/13 180-Day	The Zenith Fenestrated AAA Endovascular Graft	Cook Incorporated  Bloomington, IN 47402	Approval of the post-approval study protocol.
P020050/S013 5/15/13 Special	WaveLight® EX 500 Excimer Laser System	Alcon Research, Ltd.  Fort Worth, TX 76134	Approval for the labeling changes of WaveLight® EX 500 Excimer Laser System and WaveLight Laser System.
P030002/S027 5/20/13 Panel-Track	Trulign™ Toric Posterior Chamber Intraocular Lens (Models: AT50T, BL1AT and BLU1T) and Trulign™ Toric Calculator	Bausch + Lomb Aliso Viejo, CA 92656	Approval for the Trulign™ Toric Posterior Chamber Intraocular Lens (Models: AT50T, BL1AT and BL1UT) and Trulign™ Toric Calculator.  This device is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia and postoperative refractive astigmatism secondary to removal of a cataractous lens in adult patients with or without presbyopia who desire reduction of residual refractive cylinder with increased spectacle independence and improved uncorrected near, intermediate and distance vision.
P030005/S092 5/23/13 180-Day	Intua CRT-P	Boston Scientific Corporation St. Paul, MN  55112	Approval for the Intua CRT-P.
P030008/S011 5/15/13 Special	WaveLightLaser System	Alcon Research, Ltd.  Fort Worth, TX 76134	Approval for the labeling changes of WaveLight® EX 500 Excimer Laser System and WaveLight Laser System.
P030011/S019 5/30/13 135-Day	SynCardia temporary Total Artificial Heart (TAH-t) System	SynCardia Systems, Inc.  Tucson, AZ  85713	Approval for expansion of your controlled environment suite manufacturing area.
P030017/S156 5/8/13 Real-Time	Precision Spinal Cord Stimulation System	Boston Scientific Neuromodulation Valencia, CA  91355	Approval for a colorant change to the hub portion of the Introducer, a surgical accessory for the Precision Spinal Cord Stimulation System that is used to facilitate placement of a lead into the epidural space.
P030017/S157 5/30/13 Real-Time	Precision Spinal Cord Stimulator (SCS) – Clinical Programmer	Boston Scientific Neuromodulation (BSN) Valencia, CA  91355	Approval for an update to the Clinician Programmer computer used with the Precision and Precision Spectra Spinal Cord Stimulator (SCS) systems. A tablet computer from ASUS, model EEE Slate B121, will be used to replace the current Clinician Programmer, a Toshiba model M400 laptop computer. The ASUS tablet is an off-the-shelf computer, customized to be a Clinician’s Programmer by installing the EEE Slate B121 boot and image software and configuring the system with the BN1.2 and BN3 BionicNavigator software.
P030050/S014 5/28/13 Real-Time	Sculptra and Sculptra Aesthetic	Valeant Pharmaceuticals North America LLC North Bridgewater, NJ  08807	Approval for the revision of a Precaution statement in your product label to state: SCULPTRA Aesthetic should only be used by a healthcare practitioner trained to correct shallow to deep nasolabial contour deficiencies and other facial wrinkles, in which deep dermal grid pattern (cross-hatch) injection technique is appropriate, after the healthcare practitioner is fully familiar with the product, WAS, product educational materials, and the entire package insert and patient labeling. The device, as modified, will be marketed under the trade name Sculptra Aesthetic and is indicated for use in immune-competent people as a single regimen for correction of shallow to deep nasolabial fold contour deficiencies and other facial wrinkles in which deep dermal grid pattern (cross-hatch) injection technique is appropriate.
P040044/S048 5/17/13 Real-Time	Mynx Vascular Closure Device Product Family	Access Closure, Inc. Mountain View, CA 94043	Approval for clarification and simplification of the language used in the instruction for use and removal of the sterilization indicator label from the device pouch for the Mynx Cadence Vascular Closure Device, 6F/7F MynxGrip Vascular Closure Device, and 5F MynxGrip Vascular Closure Device.
P050018/S018 5/20/13 180-Days	AngioSculpt PTCA Scoring Balloon Catheter	AngioScore, Inc.  5055 Brandin Court  Fremont, CA  94538	Approval for revisions to the Instructions for Use labeling
P050023/S063 5/8/13 Real-Time	Lumax 300 DR-T/ Lumax 340 DR-T, Lumax 300 VR-T/ Lumax 340 VR-T, Lumax 500 DR-T/ Lumax 540 DR-T, Lumax 500 VR-T/ Lumax 540 VR-T, Lumax 540 VR-T DX, Lumax 600 DR-T/ Lumax 640 DR-T, Lumax 600 VR-T/ Lumax 640 VR-T, Lumax 640 VR-T DX, Lumax 700 DR-T/ Lumax 740 DR-T, Lumax 700 VR-T/ Lumax 740 VR-T, Lumax 740 VR-T DX, Ilesto 7 VR-T/ Ilesto 5 VR-T, Ilesto 7 VR-T DX/Ilesto 5 VR-T DX, Ilesto 7 DR-T/ Ilesto 5 DR-T, Iforia 7 VR-T/ Iforia 5 VR-T, Iforia 7 VR-T DX/ Iforia 5 VR-T DX, Iforia 7 DR-T/ Iforia 5 DR-T, Kronos LV-T, Lumax 300 HF-T/ Lumax 340 HF-T, Lumax 500 HF-T/ Lumax 540 HF-T, Lumax 600 HF-T / Lumax 640 HF-T, Lumax 700 HF-T/ Lumax 740 HF-T, Ilesto 7  HF-T/Ilesto 5 HF-T, Iforia 7 HF-T/Iforia 5 HF-T	Biotronik, Inc. Lake Oswego, OR 97035	Approval for an updated Version 3.22.0 of Home Monitoring Service Center including the features: 1) Implementation of Remote Scheduling; and 2) Automatic export of EHR data.
P050028/S030 5/3/13 Real-Time	COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test, v2.0	Roche Molecular Systems, Inc.  Pleasanton, CA 94588	Approval for changes to the Test Definition File (TDF) in order to implement a new sample preparation sequence for the Cobas AmpliPrep instrument.
P050050/S004 5/1/13 180-Day	Scandinavian Total Ankle Replacement (STAR) System	Small Bone Innovations, Inc. Morrisville, PA  19067	Approval for a manufacturing site located at Zrinski Ag in Wurmlingen, Germany.
P060008/S097 5/1/13 180-Day	TAXUS Liberté Paclitaxel-Eluting Coronary Stent System	Boston Scientific Corporation  MN 55311	Approval for the labeling update for post approval study findings for the TAXUS Liberté Paclitaxel-Eluting Coronary Stent System.
P060025/S010 5/29/13 Real-Time	3f Aortic Bioprosthesis	Medtronic Heart Valves Santa Ana, CA 92705	Approval for changes to the rinsing and fixations solutions used in the manufacture of the device. The device, as modified, will be marketed under the trade name 3f Aortic Bioprosthesis, Model 1000 and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
P060027/S038 5/9/13 180-Day	Paradym RF CRT-D 9750	Sorin CRM USA, Inc. Plymouth, MN 55441	Approval for the Smartview Home Monitor. The device, as modified, will be marketed under the trade name Smartview Home Monitor and is indicated for use with Sorin radio frequency implanted cardiac device only and any household traditional (analog type) telephone land line; It will not operate with other lines such as and not limited to digital, DSL or optical for the PSTN device and the SMARTVIEW monitor is designed for use with the Sorin radio frequency implanted cardiac device only for GPRS devices.
P060040/S023 5/7/13 180-Day	Thoratec HeartMate II Left Ventricular Assist System (LV AS)	Thoratec Corporation Pleasanton, CA 94588	Approval for a new System Controller for the device.
P070008/S041 5/8/13 Real-Time	Stratos LV-T, Evia HF-T	Biotronik, Inc. Lake Oswego, OR 97035	Approval for an updated Version 3.22.0 of Home Monitoring Service Center including the features: 1) Implementation of Remote Scheduling; and 2) Automatic export of EHR data.
P070015/S109 5/23/13 180-Day	XIENCE V Everolimus Eluting Coronary Stent System	Abbott Vascular, Inc.  Santa Clara, CA 95052	Approval of the post-approval study protocol.
P070016/S007 5/20/13 Special	Zenith TX2 Thoracic Endovascular Fenestrated Stent Graft	Cook Incorporated  Bloomington, IN 47402	Approval for updating several sections in the IFU regarding maintaining hemostasis, trigger wire release, and MRI safety information.
P070026/S013 5/7/13 Special	DePuy CERMAX® Ceramic Total Hip System	DePuy Orthopaedics, Incorporated  Warsaw, IN  46581	Approval for a change in the labeling of the package insert and surgical technique.
P080003/S001 5/16/13 Panel-Track	Selenia Dimensions 3D System	Hologic, Inc.  Bedford, MA  01730	Approval for the Selenia Dimensions 3D System.  This device is indicated to generate digital mammographic images that can be used for screening and diagnosis of breast cancer. The Selenia Dimensions (2D or 3D) system is intended for use in the same clinical applications as a 2D mammography system for screening mammograms. Specifically, the Selenia Dimensions system can be used to generate 2D digital mammograms and 3D mammograms. Each screening examination may consist of: a 2D FFDM image set; or a 2D and 3D image set, where the 2D image can be either a FFDM or a 2D image generated from the 3D image set. The Selenia Dimensions system may also be used for additional diagnostic workup of the breast.
P080012/S017 5/16/13 Special	Prometra Programmable Infusion System	Flowonix Medical, Incorporated  Mt. Olive, NJ 07828	Approval for an MRI information bracelet.
P080027/S011 5/28/13 Special	OraQuick® HCV Rapid Antibody Test	OraSure Technologies, Inc.  Bethlehem, PA 18015	Approval of the addition of a visual inspection step in the OraQuick® HCV Rapid Antibody Test Assay Card manufacturing process.
P090013/S085 5/24/13 180-Day	Revo MRI	Medtronic, Inc. Moundsview, MN 55112	Approval for the MyCareLink Patient Monitor Models 24950, 24951, Reader Model 24955, and accessories, which support the devices.
P090018/S019 5/17/13 Special	Esteem® Implantable Hearing System	Envoy Medical Corporation  St Paul, MN  55110	Approval for the following: 1) revisions to the instructions for use for the implanting surgeon; 2) a manual to inform audiologists on the programming of the Esteem System; and 3) for making manuals, which are made redundant by the former labeling changes, obsolete.
P100012/S004 5/3/13 180-Day	NuVasive PCM Cervical Disc	Nuvasive, Inc.  San Diego, CA 92121	Approval of the post-approval study protocol.
P100016/S001 5/28/13 180-Day	Aaris™ Acrylic Intraocular Lens (IOL), and EC-3 Precision Aspheric Lens (PAL)	Aaren Scientific Inc.  Ontario, CA  91761	Approval for a change to the trade name of the approved lenses and labeling changes to the unit carton, including a change to the color scheme and format. The device, as modified, will be marketed under the trade name Aaris™ Acrylic Intraocular Lens (IOL), Models EC-3 and EC-3 Precision Aspheric Lens (PAL) and is indicated for primary implantation in the capsular bag of the eye for the visual correction of aphakia in adult patients in whom a cataractous lens has been removed.
P100021/S024 5/3/13 180-Day	Endurant II Stent Graft System	Medtronic Vascular, Inc.  Santa Rosa, CA 95403	Approval for a sterilization site located at Synergy Health Sterilization UK LTD in Daventry, United Kingdom.
P100023/S069 5/15/13 180-Day	ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System (Monorail and OTW)	Boston Scientific Corporation Maple Grove, MN 55311	Approval for a manufacturing site located at Ballybrit Business Park, in Galway, Ireland.
P100025/S002 5/23/13 180-Day	BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA)	Otsuka America Pharmaceutical, Inc. Rockville, MD 20850	Approval for a manufacturing site located at Sharp Corporation, in Allentown, PA.
P100025/S004 5/29/13 180-Day	BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation Application (pUHR-CA), Version 1.0	Otsuka America Pharmaceutical, Inc.  Rockville, MD 20850	Approval for changes to the labeling for the BreathTek® UBT for H. pylori Kit (BreathTek UBT Kit) and Pediatric Urea Hydrolysis Rate Calculation application (pUHR-CA), Version 1.0, including the package insert and How to Guide.
P100041/S027 5/22/13 Special	Edwards SAPIEN™ Transcatheter Heart Valve Crimper, and all SAPIEN™ Accessories	Edwards Lifesciences, LLC Irvine, CA 92614	Approval for addition of polyethylene foam to the base of the Crimper during packaging, a change to the Crimper package release temperature set point, and addition of pouch integrity inspections for all SAPIEN™ accessories.
P100044/S004 5/22/13 180-Day	Propel™ Sinus Implant	Intersect ENT Menlo Park. CA 94025	Approval for a revised drug release specification range for the drug release test per a condition of approval.
P100047/S014 5/15/13 180-Day	HeartWare Ventricular Assist System	HeartWare Inc.  Miami Lakes, FL 33014	Approval for a manufacturing site located at Heart Ware in Miami Lakes, Florida.
P100047/S019 5/22/13 Real-Time	HeartWare® Ventricular Assist System	HeartWare Inc.  Miami Lakes, FL 33014	Approval for a change of the adhesive tape and the addition of 4 ribs (posts/shelves) to hold the LCD glass in its position on the controller.
P110007/S003 5/28/13 135-Day	Healon EndoCoat Ophthalmic Viscoelastic Devices (OVD)	Abbott Medical Optics Inc.  Santa Ana, CA 92705	Approval for the use of a new raw material supplier for the nutrient source used in the sodium hyaluronate manufacturing process.
P110021/S013 5/22/13 Special	Edwards SAPIEN™ Transcatheter Heart Valve Crimper and all SAPIEN™ Accessories	Edwards Lifesciences, LLC Irvine, CA  92614	Approval for addition of polyethylene foam to the base of the Crimper during packaging, a change to the Crimper package release temperature set point, and addition of pouch integrity inspections for all SAPIEN™ accessories.
P110042/S005 5/9/13 Real-Time	Programmer Model Q-TECH	Cameron Health Inc. San Clemente, CA 92673	Approval for disabling of the Programmer Model Q-TECH modem port.

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
P790005/S049 5/28/13	EBI OsteoGen™ Implantable Bone Growth Stimulators	Biomet Spine & Bone Healing Technologies  Parsippany, NJ 07054	Acceptance of a replacement coin cell battery.
P810002/S085 5/30/13	St. Jude Medical Mechanical Heart Valves	St. Jude Medical St. Paul, MN  55117	Change to the clean room for the SJM Mechanical Heart Valves, and a change in the VAVGJ package sealing parameters.
P820021/S036 5/8/13	Vifilcon A Contact Lenses for Extended Wear	CIBA Vision Corporation Duluth, GA 30097	Test method changes and/or improvements.
P830061/S091 5/23/13	CapSure Sense Bipolar Lead	Medtronic, Inc. Mounds View, MN 55112	Use of a new sterilizer and aerator.
P830061/S092 5/29/13	CapSure Lead, Vitatron Crystaline Lead, Vitatron Excellence PS+ Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P840001/S239 5/16/13	Vectris™ SureScan® MRI 1X8 Leads and  Vectris™ 1X8 Trialing Leads	Medtronic Neuromodulation Minneapolis, MN 55432	Modifications to the manufacturing process for leads used with implantable neurostimulators, external neurostimulators, and accessories for spinal cord stimulation.
P840060/S040 5/21/13	PMMA Posterior Chamber Intraocular Lenses	Alcon Research Ltd.  Fort Worth, TX 76134	Relocate packaging and labeling equipment.
P850035/S035 5/28/13	SpF® Implantable Spinal Fusion Stimulators	Biomet Spine & Bone Healing Technologies  Parsippany, NJ 07054	Acceptance of a replacement coin cell battery.
P850089/S097 5/29/13	CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Impulse II Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P860003/S73 5/6/13	THERAKOS CELLEX Photopheresis System (CELLEX System)	Therakos, Inc.  Raritan, NJ  08869	Manufacturing process change for one of the CELLEX System components.
P880006/S086 5/14/13	Regency, Sensolog, Dialog	St. Jude Medical Sylmar, CA  91342	Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P880086/S232 5/15/13	AddVent, Affinity, Identity, Verity, Integrity, Victory, Zephyr, Accent, Trilogy, Synchrony, Paragon, Phoenix, Entity, Sustain XL	St. Jude Medical Sylmar, CA  91342	Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P880086/S233 5/30/13	Identity, Verity, Integrity, Victory, Zephyr, Accent family of Pacemaker Devices	St. Jude Medical Sylmar, CA  91342	Alternate assembly process for attaching the X-Ray Tag to the hybrid.
P880087/S022 5/21/13	PMMA Single-Piece Anterior	Alcon Research Ltd.  Fort Worth, TX 76134	Relocate packaging and labeling equipment.
P890003/S275 5/29/13	CapSure Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P900052/S018 5/13/13	Port-A-Cath Low Profile Epidural Implantable Access System	Smiths Medical ASD, Inc.  St. Paul, MN  55112	Change in the synthesis of polytetrafluoro-ethylene (PTFE), a substance used in the manufacturing of the coating system for the guidewire contained in the Port-A-Cath II Low Profile Epidural Implantable Access System. This change in the synthesis of PTFE is required to conform to U.S. Environmental Agency 2010/2015 PFOA Stewardship Program related to the use of perfluorooctanoic acid (PFOA).
P910023/S314 5/14/13	Cadence, Cadet, Contour, Contour II/MD, Angstrom II/MD, Profile II/MD, Photon, Photon Micro, Current, Current +, Atlas II/Atlas II+, Atlas/Atlas +, Epic II/Epic II+, Epic/Epic +, Convert/Convert +, Current RF, Current +, Current Accel, Fortify, Fortify Assura, Ellipse	St. Jude Medical Sylmar, CA  91342	Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P920015/S111 5/29/13	Sprint Quattro Lead, Subcutaneous Lead, Transvene SVC Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P930014/S068 5/21/13	AcrySof Intraocular Lenses	Alcon Research Ltd.  Fort Worth, TX 76134	Relocate packaging and labeling equipment.
P930039/S087 5/23/13	CapSureFix Novus Lead	Medtronic, Inc. Mounds View, MN 55112	Use of a new sterilizer and aerator.
P930039/S088 5/29/13	CapSureFix Lead, CapSureFix Novus Lead, SureFix Lead, Vitatron Crystalline Lead, Vitatron Pirouet Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P950005/S044 5/29/13	Celsius, Celsius RMT, EZ Steer Non-Temp Sensing Ablation Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of an alternate supplier for the extrusion and braiding process for the family of products.
P950008/S009 5/15/13	Silikon 1000 Ocular Endotamponade	Alcon Laboratories, Inc. Fort Worth, TX  76134	Alternate thermal extraction.
P950022/S086 5/29/13	Durata Family of High Voltage Leads	St. Jude Medical Sylmar, CA  91342	Add an alternate supplier of a lead tip component.
P950024/S049 5/29/13	CapSure Epicardial Pacing Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P950037/S122 5/17/13	Dextrus, Selox, Setrox S, Solox, Tilda Leads	Biotronik, Inc.  Lake Oswego, OR 97035	Use a new maximum sterilization chamber load at the contract sterilizer for their marketed leads.
P950037/S123 5/29/13	Selox, Setrox S, Solox, Ecuro, Effecta, Estella, Evia, Dextrus	Biotronik, Inc. Lake Oswega, OR 97035	A change in sterilization load configuration; 2) change in sterilization pre-conditioning; 3) sterilization injection parameter changes; and 4) change to the process challenge device.
P960009/S171 5/29/13	Deep Brain Stimulation (DBS) Leads	Medtronic, Inc.  Minneapolis, MN 55432	Implement a new inspection process to verify the distal end surface straightness of the DBS leads.
P960013/S075 5/29/13	Tendril STS Model 2088TC Lead	St. Jude Medical Sylmar, CA  91342	Add an alternate supplier of a lead tip component.
P970003/S161 5/3/13	VNS Therapy® System – Lead Assembly	Cyberonics, Inc. Houston, TX  77058	Addition of an alternative elastomer mixing process for various lead assembly models.
P970003/S163 5/21/13	VNS Therapy® Generator (Pulse and Pulse Duo),  VNS Therapy® Generator (AspireHC)	Cyberonics, Inc. Houston, TX  77058	Addition of an alternative laser welding system, which is used to weld the case halves and anchor tabs of the VNS Therapy® Generators.
P970013/S056 5/14/13	Microny	St. Jude Medical Sylmar, CA  91342	Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P970051/S109 5/6/13	Nucleus 24 Cochlear Implant System	Cochlear Americas Centennial, Colorado 80111	Upgrades to the Nucleus 5 Service Test System software.
P980016/S407 5/3/13	Intrinsic, Marquis, Marquis, Maximo II, Maximo, Protecta, Protecta XT, Secura, Virtuoso II, Evera S, and Evera XT ICD Families	Medtronic, Inc. Mounds View, MN 55112	Implementation of an updated acceptance criterion for evaluation of insulator materials used in the manufacture of the subject ICDs and CRT-D devices.
P980016/S408 5/3/13	Evera S DR, Evera S VR, Evera XT DR	Medtronic CRDM Mounds View, MN 55112	Addition of a specific acceptance criterion to allow delamination for the lower wire bond pad on the U31 FET; 2) two process adjustment changes for the integrated circuit at Medtronic supplier 3) the implementation of additional tooling for the case liner assembly manufacturing Process; 4) a change to the hybrid CD Surge manufacturing test software; 5) three changes including the implementation of a burn-in oven for the recovery and final voltage measurements steps for the batteries of the subject devices, corrections to the subject systems’ battery test specification to align with measurement system capabilities, and consolidation of measurement steps within the burn in test process; and 6) the implementation of additional laser welders to increase manufacturing capacity.
P980016/S409 5/3/13	Evera S DR, Evera S VR, Evera XT DR	Medtronic CRDM  Mounds View, MN 55112	The implementation of FACTORY works Release 8.0 and MES Web Services Release 2.1; 2) the approval of manufacturing lines in a new extension of a controlled environment area; 3) new pressure test equipment to verify hermeticity; 4) modifications to a controlled environment; 5) a change to the descum and cleaning process for the 3um CMOS Integrated Circuit; and 6) a new software version for process data collection software at a Medtronic supplier.
P980016/S410 5/7/13	Evera S DR, Evera S VR, Evera XT DR, Evera XT VR,	Medtronic, Inc. Mounds View, MN 55112	Seven previously approved manufacture changes for the devices. Those are: 1) update the CMOS IC Process Flow Changes at your supplier; 2) update the test software and hardware on the Teradyne Test Platform for M019 and M017 ICs; 3) add the High Temperature Monitor to High Power Lean Line; 4) update the Automated Assembly Equipment Controller (AAEC); 5) implement a new Cleaning process and a Curing Oven; 6) implement a manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations; and 7) update to the Test System Software Shell.
P980016/S414 5/14/13	Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD	Medtronic, Inc. Mounds View, MN 55112	Butted Contact etch time change for the M016 and M017 Integrated Circuits.
P980016/S415 5/22/13	Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD	Medtronic, Inc. Mounds View, MN 55112	Second source supplier for a thick film chip resistor.
P980023/S053 5/17/13	Kainox VCS, Linox, Linox Smart, Vigila, Volta Leads	Biotronik, Inc.  Lake Oswego, OR 97035	Use a new maximum sterilization chamber load at the contract sterilizer for their marketed leads.
P980023/S055 5/29/13	Kainox VCS, Linox, Vigila, Volta	Biotronik, Inc. Lake Oswega, OR 97035	A change in sterilization load configuration; 2) change in sterilization pre-conditioning; 3) sterilization injection parameter changes; and 4) change to the process challenge device.
P980035/S318 5/7/13	Advisa MRI	Medtronic, Inc. Mounds View, MN 55112	Seven previously approved manufacture changes for the devices. Those are: 1) update the CMOS IC Process Flow Changes at your supplier; 2) update the test software and hardware on the Teradyne Test Platform for M019 and M017 ICs; 3) add the High Temperature Monitor to High Power Lean Line; 4) update the Automated Assembly Equipment Controller (AAEC); 5) implement a new Cleaning process and a Curing Oven; 6) implement a manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations; and 7) update to the Test System Software Shell.
P980035/S322 5/14/13	Advisa DR IPG, Advisa DR MRI IPG	Medtronic, Inc. Mounds View, MN 55112	Butted Contact etch time change for the M016 and M017 Integrated Circuits.
P980035/S323 5/23/13	Adapta/Versa/Sentia IPG	Medtronic, Inc. Mounds View, MN 55112	Use of a new sterilizer and aerator.
P980049/S082 5/3/13	Paradym VR and DR ICDs	Sorin CRM USA, Inc. Arveda, CO  80004	Extending the use of a plasma cleaning step used during the micro-electronic assembly process.
P980050/S083 5/29/13	Transvene Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P990025/S037 5/29/13	NaviStar, NaviStar RMT, EZ Steer Nay Catheters and BWI Cables	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of an alternate supplier for the extrusion and braiding process for the family of products.
P990075/S023 5/15/13	Mentor Saline-Filled Breast Implants	Mentor Worldwide LLC  Santa Barbara, CA 93111	Add an additional supplier of the diaphragm valve component used in the manufacture of the Mentor Saline-Filled Breast Implants.
P990081/S018 5/13/13	PATHWAY Anyi-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody	Ventana Medical Systems, Inc. Tucson, AZ  85755	Addition of a new supplier of Printed Circuit Board Assemblies used in the production of the BenchMark ULTRA and BenchMark XT instruments.
P000021/S025 5/28/13	Dimension Vista® TPSA Flex® Reagent Cartridge	Siemens Healthcare Diagnostics Inc. Newark DE  19714	Change the supplier for Dextran T110 from Sigma Adrich Fine Chemicals (SAFC) to Pharmacomos and to bring phthalocyanine manufacture in-house at the Siemens Healthcare Diagnostics, Newark, Delaware site and the scale-up of the sensibead concentrate production from 150g per lot size to 300g.
P000025/S069 5/29/13	Mi1000 MED-EL CONCERT Cochlear Implants	MED-EL Elektro-Medizinische Geräte GmbH Fürstenweg, Austria 77a	Additional supplier of the 16-Pin Feedthrough Assembly component which is used in the production of the Mi1000 MED-EL CONCERT Cochlear Implants.
P000036/S016 5/21/13	Dermagraft	Shire Regenerative Medicine, Inc.  La Jolla, CA 92121	Change in the software used to regulate the Dermagraft cell culture process.
P000036/S017 5/23/13	Dermagraft	Shire Regenerative Medicine, Inc.  La Jolla, CA 92121	Qualification of additional seeding vessels, and proposed a change in the type of material used for the tubing and manifold assembly connector fittings.
P000036/S018 5/21/13	Dermagraft	Shire Regenerative Medicine, Inc.  La Jolla, CA 92121	Addition of a Laminar Flow Hood, Freezer Replacement (Single to Dual compressor), Distribution Freezer transfer to Warehouse for Sample Storage, and an addition of a Liquid Nitrogen Storage Freezer.
P010015/S199 5/14/13	Consulta CRT-P, Syncra CRT-P	Medtronic, Inc. Mounds View, MN 55112	Butted Contact etch time change for the M016 and M017 Integrated Circuits.
P010015/S200 5/29/13	Attain Bipolar OTW Lead, Left Ventricular Pacing Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P010031/S370 5/3/13	Concerto, Consulta, Insync III Marquis, and InSync Maximo CRT-D families: Concerto II, Brava, Viva S, Viva XT, Maximo II, Protecta, and Protecta XT ICD Families	Medtronic, Inc. Mounds View, MN 55112	Implementation of an updated acceptance criterion for evaluation of insulator materials used in the manufacture of the subject ICDs and CRT-D devices.
P010031/S371 5/7/13	Brava CRT-D, Viva S CRT-D, Viva XT CRT-D	Medtronic, Inc. Mounds View, MN 55112	Seven previously approved manufacture changes for the devices. Those are: 1) update the CMOS IC Process Flow Changes at your supplier; 2) update the test software and hardware on the Teradyne Test Platform for M019 and M017 ICs; 3) add the High Temperature Monitor to High Power Lean Line; 4) update the Automated Assembly Equipment Controller (AAEC); 5) implement a new Cleaning process and a Curing Oven; 6) implement a manufacturing execution system version 7.9 at various internal suppliers and final device manufacturing locations; and 7) update to the Test System Software Shell.
P010031/S374 5/14/13	Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT  CRT-D, Viva S CRT-D, Viva XT CRT-D	Medtronic, Inc. Mounds View, MN 55112	Butted Contact etch time change for the M016 and M017 Integrated Circuits.
P010031/S375 5/22/13	Brava CRT-D, Concerto II CRT-D, Consulta ICD, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva S CRT-D, Viva XT CRT-D	Medtronic, Inc. Mounds View, MN 55112	Second source supplier for a thick film chip resistor.
P010068/S034 5/29/13	Celsius DS, NaviStar DS, NaviStar RMT DS, EZ Steer Nav DS Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of an alternate supplier for the extrusion and braiding process for the family of products.
P020004/S081 5/2/13	GORE® EXCLUDER® AAA Endoprosthesis	W.L. Gore and Associates Flagstaff, AZ  86004	Alternate FEP film supplier and a change from in-process testing to the raw material testing for certain tests performed by the new qualified supplier.
P020027/S020 5/28/13	Dimension Vista® FPSA Flex® Reagent Cartridge	Siemens Healthcare Diagnostics Inc. Newark DE  19714	Change the supplier for Dextran T110 from Sigma Adrich Fine Chemicals (SAFC) to Pharmacomos and to bring phthalocyanine manufacture in-house at the Siemens Healthcare Diagnostics, Newark, Delaware site and the scale-up of the sensibead concentrate production from 150g per lot size to 300g.
P020055/S007 5/13/13	PATHWAY Anti-c-KIT (9.7) Rabbit Monoclonal Primary Antibody	Ventana Medical Systems, Inc. Tucson, AZ  85755	Addition of a new supplier of Printed Circuit Board Assemblies used in the production of the BenchMark ULTRA and BenchMark XT instruments.
P030009/S064 5/8/13	Integrity Coronary Stent System	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Change to the in-process sampling requirements of several extruded tubing components.
P030017/S161 5/1/13	Precision and Precision Spectra Spinal Cord Stimulator Systems	Boston Scientific Corporation  Valencia, CA  91355	Manufacturing facility move for the packaging pouch supplier.
P030031/S052 5/29/13	Celsius ThermoCool, Celsius RMT ThermoCool Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of an alternate supplier for the extrusion and braiding process for the family of products.
P030035/S110 5/14/13	Frontier, Frontier II, Anthem	St. Jude Medical Sylmar, CA  91342	Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P030035/S111 5/30/13	Frontier, Frontier II, Anthem family of CRT-P Devices	St. Jude Medical Sylmar, CA  91342	Alternate assembly process for attaching the X-Ray Tag to the hybrid.
P030036/S057 5/29/13	SelectSecure Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P030054/S245 5/14/13	Epic HF, Epic + HF, Epic II HF, Epic II+ HF, Atlas HF, Atlas + HF, Atlas II HF, Atlas II+ HF, Promote,  Promote +, Promote HF, Promote Accel, Unify, Unify Assura, Promote Q, Promote Quadra, Quadra Assura, Unify Quadra	St. Jude Medical Sylmar, CA  91342	Alternate sterilization cycle at the Puerto Rico manufacturing facility.
P040020/S047 5/21/13	AcrySof ReSTOR Intraocular Lenses	Alcon Research Ltd.  Fort Worth, TX 76134	Relocate packaging and labeling equipment.
P040027/S029 5/2/13	GORE® VIATORR® TIPS Endoprosthesis	W.L. Gore and Associates Flagstaff, AZ  86004	Alternate FEP film supplier and a change from in-process testing to the raw material testing for certain tests performed by the new qualified supplier.
P040036/S036 5/29/13	NaviStar-, Navistar RMT-, EZ Steer- ThermoCool Catheters	Biosense Webster, Inc. Diamond Bar, CA 91765	Addition of an alternate supplier for the extrusion and braiding process for the family of products.
P040037/S048 5/2/13	GORE® VIABAHN® Endoprosthesis	W.L. Gore and Associates Flagstaff, AZ  86004	Alternate FEP film supplier and a change from in-process testing to the raw material testing for certain tests performed by the new qualified supplier.
P040037/S049 5/14/13	GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface	W.L. Gore and Associates, Inc. Flagstaff, AZ  86001	Automate selection of raw material/ components during device/catheter assembly.
P040043/S052 5/2/13	GORE® TAG® Thoracic Endoprosthesis	W.L. Gore and Associates Flagstaff, AZ  86004	Alternate FEP film supplier and a change from in-process testing to the raw material testing for certain tests performed by the new qualified supplier.
P050023/S064 5/17/13	Corox OTW 75 UP Steroid, Corox OTW 85 UP Steroid Leads	Biotronik, Inc.  Lake Oswego, OR 97035	Use a new maximum sterilization chamber load at the contract sterilizer for their marketed leads.
P050023/S065 5/29/13	Ilesto, Iforia, Lumax	Biotronik, Inc. Lake Oswega, OR 97035	A change in sterilization load configuration; 2) change in sterilization pre-conditioning; 3) sterilization injection parameter changes; and 4) change to the process challenge device.
P050028/S031 5/7/13	COBAS® TaqMan HBV Test For Use With The High Pure System and  COBAS® AmpliPrep/ COBAS® TaqMan® HBV Test version 2.0	Roche Molecular Systems, Inc.  Pleasanton, CA 94588	Change for an optimization of the kit QC functional testing calculation method.
P050037/S037 5/30/13	Radiesse Injectable Implant	Merz Aesthetics, Inc.  Franksville, WI 53126	Addition of a new syringe component supplier.
P050042/S024 5/22/13	ARCHITECT Anti-HCV	Abbott Laboratories Abbott Park, IL 60064	Change to a supplier quality control test method and acceptance specifications for an incoming bulk material used in the manufacture of the ARCHITECT Anti-HCV test kit.
P050052/S040 5/30/13	Radiesse Injectable Implant	Merz Aesthetics, Inc.  Franksville, WI 53126	Addition of a new syringe component supplier.
P060002/S032 5/29/13	Bard® FLAIR® Endovascular Stent Graft	Bard Peripheral Vascular, Inc. Tempe, AZ  85281	Update the bond peel inspection.
P060027/S050 5/3/13	Paradym CRT-D and Paradym RF CRT-D	Sorin CRM USA, Inc. Arveda, CO  80004	Extending the use of a plasma cleaning step used during the micro-electronic assembly process.
P060033/S074 5/8/13	Endeavor Sprint Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Change to the in-process sampling requirements of several extruded tubing components.
P060033/S076 5/29/13	Endeavor Sprint Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Alternate analytical testing supplier.
P060039/S056 5/29/13	Attain StarFix Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P070007/S037 5/2/13	Talent AAA Stent Graft System	Medtronic Vascular Santa Rosa, CA 95403	Add manufacturing steps related to the stent ring and markers to an existing internal manufacturing facility.
P070008/S042 5/17/13	Celerity and Corox Leads	Biotronik, Inc.  Lake Oswego, OR 97035	Use a new maximum sterilization chamber load at the contract sterilizer for their marketed leads.
P070008/S043 5/29/13	Stratos, Evia HF, Entovis HF, Celerity, Corox	Biotronik, Inc. Lake Oswega, OR 97035	A change in sterilization load configuration; 2) change in sterilization pre-conditioning; 3) sterilization injection parameter changes; and 4) change to the process challenge device.
P070027/S036 5/2/13	Talent Thoracic Stent Graft System	Medtronic Vascular Santa Rosa, CA 95403	Add manufacturing steps related to the stent ring and markers to an existing internal manufacturing facility.
P080006/S053 5/29/13	Attain Ability Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P080011/S023 5/7/13	CooperVision Biofinity (comfilcon A) Soft (Hydrophilic) Extended-Wear Contact Lenses	CooperVision, Incorporated Pleasanton, CA 94588	Minor modification to the manufacturing process.
P080026/S007 5/28/13	Abbott RealTime HBV	Abbott Molecular Inc.  Des Plaines, IL 60018	Change to the sampling plan for the reagent vial filling procedure for both devices.
P080030/S008 5/1/13	iStent Trabecular Micro-Bypass Stent System	Glaukos Corporation  Laguna Hills, CA 92653	Change QC testing of the iStent Trabecular Micro-Bypass Stent System.
P090006/S010 5/22/13	Complete SE Vascular Stent System	Medtronic Vascular Santa Rosa, CA 95403	Alternate site for the packaging pouch supplier.
P090013/S092 5/14/13	CapSureFix MRI Pacemaker Lead	Medtronic Mounds View, MN 55112	Replacing the test used for in-process monitoring of an inner insulation parameter.
P090013/S095 5/14/13	Revo MRI IPG	Medtronic, Inc. Mounds View, MN 55112	Butted Contact etch time change for the M016 and M017 Integrated Circuits.
P090013/S096 5/23/13	CapSureFix MRI SureScan Lead	Medtronic, Inc. Mounds View, MN 55112	Use of a new sterilizer and aerator.
P090013/S097 5/29/13	CapSureFix MRI Lead	Medtronic, Inc. Mounds View, MN 55112	Update to the maximum sterilization load profile temperature.
P100013/S009 5/9/13	ExoSeal Vascular Closure Device	Cordis Corporation Bridgewater, NJ 08807	Change in the processing of three components from single cavity mold to multi cavity molds for the ExoSeal Vascular Closure Device.
P100017/S006 5/28/13	Abbott RealTime HCV	Abbott Molecular Inc.  Des Plaines, IL 60018	Change to the sampling plan for the reagent vial filling procedure for both devices.
P100018/S007 5/9/13	Pipeline Embolization Device	Micro Therapeutics, Inc. d.b.a. ev3 Neurovascular Irvine, CA  92618	Manufacturing process change for the protective coil of the Pipeline Embolization Device delivery system.
P100021/S025 5/2/13	Endurant Stent Graft System	Medtronic Vascular Santa Rosa, CA 95403	Add manufacturing steps related to the stent ring and markers to an existing internal manufacturing facility.
P100027/S008 5/13/13	INFORM HER2 Dual ISH DNA Probe Cocktail	Ventana Medical Systems, Inc. Tucson, AZ  85755	Addition of a new supplier of Printed Circuit Board Assemblies used in the production of the BenchMark ULTRA and BenchMark XT instruments.
P100027/S010 5/29/13	INFORM HER2 Dual ISH DNA Probe Cocktail	Ventana Medical Systems, Inc. Tucson, AZ  85755	Qualification of a new supplier for a raw material that is used in the manufacture of the detection kit associated with the INFORM HER-2 Dual ISH DNA Probe Cocktail. As part of this change in raw material, a change in the cell media used to grow the anti-DNP antibody is also being implemented.
P100040/S011 5/2/13	Valiant Thoracic Stent Graft System	Medtronic Vascular Santa Rosa, CA 95403	Add manufacturing steps related to the stent ring and markers to an existing internal manufacturing facility.
P110007/S004 5/8/13	AMO Healon EndoCoat Ophthalmic  Viscosurgical Device (OVD), (3% Sodium Hyaluronate)	Abbott Medical Optics, Inc.  Santa Ana, CA 92705	Transfer the preparation of the working cell bank to Lifecore Biomedical.
P110013/S010 5/8/13	Resolute Integrity Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Change to the in-process sampling requirements of several extruded tubing components.
P110013/S013 5/29/13	Endeavor Sprint Zotarolimus-Eluting Coronary Stent System	Medtronic Vascular, Inc. Santa Rosa, CA 95403	Alternate analytical testing supplier.
P110019/S044 5/21/13	XIENCE XPEDITION™ Everolimus Eluting Coronary Stent System (XIENCE XPEDITION, XIENCE XPEDITION Small Vessel [SV], and XIENCE XPEDITION LL) in the RX Platform	Abbott Vascular  Temecula, CA  92590	Change to the stent delivery system bonding process.
P110035/S013 5/31/13	Epic Vascular Self-Expanding Stent System	Boston Scientific Corporation Maple Grove, MN 55311	Add in-process controls for a component bonding step.
P110042/S008 5/14/13	Subcutaneous Implantable Defibrillator (S-ICD) System	Boston Scientific Corporation  St. Paul, MN  55112	Use a new Receiving Inspection Workbook Tool.