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Medical Devices

April 2014 PMA Approvals

A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.

PMA Original Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P130008
4/30/14
Inspire Upper Airway Stimulation (UAS) Inspire Medical Systems, Inc.
Maple Grove, MN 55369
Approval for the Inspire Upper Airway Stimulation (UAS) system, which includes the Model 3024 Implantable Pulse Generator, the Model 4063 Stimulation Lead, the Model 4323 Sensing Lead, the Model 2740 Physician Programmer, and the Model 3032 Patient Programmer. The device is used to treat a subset of patients with moderate to severe Obstructive Sleep Apnea (OSA) (Apnea-hypopnea Index [AHI] of greater or equal to 20 and less than or equal to 65). Inspire UAS is used in adult patients 22 years of age and older who have been confirmed to fail or cannot tolerate Positive Airway Pressure (PAP) treatments (such as continuous positive airway pressure [CPAP] or bilevel positive airway pressure [BPAP] machines) and who do not have a complete concentric collapse at the soft palate level.  PAP failure is defined as an inability to eliminate OSA (AHI of greater than 20 despite PAP usage) and PAP intolerance is defined as: 1) Inability to use PAP (greater than 5 nights per week of usage; usage defined as greater than 4 hours of use per night); or 2) Unwillingness to use PAP (for example, a patient returns the PAP system after attempting to use it).

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
P790002/S031
4/30/14
Real-Time
Biomet® EBI Bone Healing System EBI, LLC
Parsippany, NJ 07054
Approval for minor modifications to the software to prevent a “Cannot Treat” error.
P810006/S046
4/8/14
135-Day
Collastat Absorbable Collagen Hemostatic Agent Integra Life Sciences Corporation
Plainsboro, NJ 08536
Approval for the following proposed changes: 
1) Cleaning validation for the Microfibrillar Grinding process Equipment;
2) Establishment of Dirty Hold Time;
3) Total Organic Carbon (TOC) Recovery Study for Swab and Rinse on Stainless Steel surfaces; and
4) TOC Recovery Study for Swab and Rinse on Teflon surfaces.
P810006/S047
4/4/14
135-Day
CollaStat Absorbable Collagen Hemostatic Sponge
CollaStat Absorbable Collagen Hemostatic Agent-Microfibrillar Form
Integra Life Sciences Corporation
Plainsboro, NJ 08536
Approval for the following proposed changes:
1) Change in cleaning detergent from MetriZyme (formulated enzymatic cleaner) to CIP-100 (formulated alkaline cleaner);
2) Establishment of an equipment Dirty Hold time (DHT) of 24-hours;
3)  Utilization of 70% Isopropyl Alcohol (IPA), as required;
4) Utilization of Sodium Lauryl Sulfate (SLS), as required; and
5) Establishing the use of Total Organic Carbons (TOCs) as a method to test for residues.
P830055/S141
4/25/14
Real-Time
LCS Total Knee System DePuy Orthopaedics, Incorporated
Warsaw, IN
46581
Approval for the addition of TruMatch Resection Guides for use with approved  components (Attune Rotating Platform Tibial and Femoral Components).
P830055/S142
4/18/14
Special
LCS® Total Knee System DePuy Orthopaedics, Incorporated
Warsaw, IN
46582
Approval for changes to the labeling (surgical technique) that add or strengthen an instruction that is intended to enhance the safe use of the device.
P840001/S267
4/30/14
Special
Prime-ADVANCED® SureScan® MRI; RestorePrime®;
Prime-ADVANCED®; Itrel®4; Restore®; Restore- ADVANCED®; Restore- ADVANCED® SureScan® MRI;
RestoreSENSOR®;RestoreSENSOR® SureScan® MRI;
RestoreULTRA®; and Restore- ULTRA® SureScan® MRI
Medtronic
Neuromodulation
Minneapolis, MN 55432
Approval to provide corrections to the labeling related to the cycling feature (alternating between therapy OFF and ON) in some neurostimulation devices used for spinal cord stimulation and deep brain stimulation.
P840062/S033
4/7/14
135-Day
CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery Integra Life Sciences Corporation
Plainsboro, NJ 08536
Approval for the following proposed changes: 
1) A new alkaline detergent for use as a cleaning agent;
2) Use of Total Organic Carbons (TOCs) as a method to test for residues;
3) Swab and rinse recovery factors and a visual limit of detection for Medical Manufacturing Area soil on Stainless Steel and Aluminum surfaces;
4) Change in Equipment Dirty Hold Times (DHTs) for the Double Density Hemostatic Dispersion, Cross-linking Process Equipment and the Mold Filling Equipment; and
5) Installation and operational qualification of a new Ultrasonicator.
P840062/S034
4/4/14
135-Day
CollaCote, CollaTape, CollaPlug Absorbable Collagen Wound Dressing for Dental Surgery Integra Life Sciences Corporation
Plainsboro, NJ 08536
Approval for the following proposed changes:
1) Change in cleaning detergent from MetriZyme (formulated enzymatic cleaner) to CIP-100 (formulated alkaline cleaner);
2) Establishment of an equipment Dirty Hold time (DHT) of 24-hours;
3)  Utilization of 70% Isopropyl Alcohol (IPA), as required;
4) Utilization of Sodium Lauryl Sulfate (SLS), as required; and
5) Establishing the use of Total Organic Carbons (TOCs) as a method to test for residues.
P850010/S044
4/8/14
135-Day
Helistat Absorbable Collagen Hemostatic Agent Integra Life Sciences Corporation
Plainsboro, NJ 08536
Approval for the following proposed changes: 
1) Cleaning validation for the Microfibrillar Grinding process Equipment;
2) Establishment of Dirty Hold Time;
3) Total Organic Carbon (TOC) Recovery Study for Swab and Rinse on Stainless Steel surfaces; and 5. TOC Recovery Study for Swab and Rinse on Teflon surfaces.
P850010/S045
4/4/14
135-Day
HeliStat, Helitene Absorbable Collagen Hemostatic Agents Integra Life Sciences Corporation
Plainsboro, NJ 08536
Approval for the following proposed changes:
1) Change in cleaning detergent from MetriZyme (formulated enzymatic cleaner) to CIP-100 (formulated alkaline cleaner);
2) Establishment of an equipment Dirty Hold time (DHT) of 24-hours;
3)  Utilization of 70% Isopropyl Alcohol (IPA), as required;
4) Utilization of Sodium Lauryl Sulfate (SLS), as required; and
5) Establishing the use of Total Organic Carbons (TOCs) as a method to test for residues.
P880006/S081
4/10/14
180-Day
Sensolog/Dialog/
Regency Family of Pacemakers
St. Jude Medical Sylmar, CA
91342
Approval for the Merlin Conduct Mobile Software Application and Model 3330 version 16.1 software for the Model 3650 Merlin Patient Care System for the devices.
P880086/S220
4/10/14
180-Day
Affinity/Integrity/
Victory/Zephyr/
Accent Family of Pacemakers
St. Jude Medical Sylmar, CA
91342
Approval for the Merlin Conduct Mobile Software Application and Model 3330 version 16.1 software for the Model 3650 Merlin Patient Care System for the devices.
P890003/S268
4/23/14
180-Day
Medtronic 2490C Carelink Remote Home Monitor Medtronic, Inc.
Mounds View, MN 55112
Approval for a manufacturing site located at Plexus (Hangzhou) Co., Ltd., in Hangzhou, Zhejiang, China.
P890003/S304
4/30/14
Real-Time
Medtronic CareLink Programmer and Medtronic Encore Programmer Medtronic, Inc.
Moundsview, MN 55112
Approval for Model SW026 application software for the Reveal LINQ Implantable Cardiac Monitors used on the Model 2090 and Encore programmers.
P890064/S029
4/14/14
180-Day
digene®Hybrid Capture® 2 (HC2) High-Risk HPV DNA Test and
digene®Hybrid Capture® 2 (HC2) HPV DNA Test
QIAGEN Incorporated
Gaithersburg, MD 20878
Approval for a manufacturing site located at QIAGEN Incorporated in  Germantown, Maryland.
P900033/S033
4/7/14
Real-Time
Integra® Dermal Regeneration Template; Integra® Meshed Dermal Regeneration Template Integra Lifesciences
Plainsboro, NJ 08536
Approval for a design change to the Integra® Dermal Regeneration Template. The design change was to produce a meshed version of the Integra® Dermal Regeneration Template. The device, as modified, will be marketed under the trade name Integra® Meshed Dermal Regeneration Template and is indicated for the post excisional treatment of life-threatening full-thickness or deep partial thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient.  It is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient.
P910023/S297
4/10/14
180-Day
Cadence/Ellipse/
Fortify/Assura Family of ICDs
St. Jude Medical Sylmar, CA
91342
Approval for the Merlin Conduct Mobile Software Application and Model 3330 version 16.1 software for the Model 3650 Merlin Patient Care System for the devices.
P910073/S123
4/24/14
Real-Time
RELIANCE IS-1, RELIANCE 4-SITE Leads Boston Scientific
St. Paul, MN
55112
Approval for a new outer sales box and closure labels for the leads.
P910077/S139
4/11/14
180-Day
VENTAK PRx AICD System, PRESCRIPTOR Programmer and Program Disk Boston Scientific Corporation
St. Paul, MN
55112
Approval for the following changes:
1) New pulse generator models listed above and modifications to the Model 2868 Programmer Application Software used to communicate with the new devices and existing devices; and
2)  Model 3140 ZOOM Wireless Transmitter and associated modifications to the Model 3120 PRM software.
P930014/S069
4/28/14
180-Day
AcrySof® Intraocular Lenses (IOLs) Alcon Laboratories, Inc.
Fort Worth, TX 76134
Approval for three alternate polypropylene materials, Basell PD702, Exxon Achieve 1605, and Exxon PP1105E1, for intraocular lens (IOL) device primary packaging.
P950029/S088
4/9/14
Real-Time
Reply SR, Reply DR, Esprit SR, Esprit DR Pacemakers Sorin CRM USA
Arvada, CO
80004
Approval for minor design changes to the SRAM and Zener Diodes for the devices.
P960006/S041
4/24/14
Real-Time
FLEXTEND Leads Boston Scientific
St. Paul, MN
55112
Approval for a new outer sales box and closure labels for the leads.
P960009/S193
4/30/14
Special
Activa® PC; Activa® SC and Activa® RC Medtronic
Neuromodulation
Minneapolis, MN 55432
Approval to provide corrections to the labeling related to the cycling feature (alternating between therapy OFF and ON) in some neurostimulation devices used for spinal cord stimulation and deep brain stimulation.
P960016/S045
4/28/14
Real-Time
Livewire TC Steerable Electrophysiology Catheter and Safire Bi-directional Ablation Catheter St. Jude Medical
St. Paul, MN
55117
Approval for changes to thermal and EGM boards, upgrade to the firmware and software, addition of remote control fiber cord lengths and updates to the instructions for use of the Ampere generator.
P960040/S306
4/11/14
180-Day
 
 
 
DYNAGEN, INOGEN, and ORIGEN Family of ICDs; COGNIS/ TELIGEN family of ICDs;
INCEPTA/ ENERGEN/
PUNCTUA Family of ICDs; Model 2868 Programmer Application Software
Boston Scientific Corporation
St. Paul, MN
55112
Approval for the following changes:
1) New pulse generator models listed above and modifications to the Model 2868 Programmer Application Software used to communicate with the new devices and existing devices; and
2)  Model 3140 ZOOM Wireless Transmitter and associated modifications to the Model 3120 PRM software.
P970004/S150
4/18/14
180-Day
Medtronic InterStim Therapy for Urinary Control Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for Medtronic’s Verify™ Evaluation System, which is a test stimulation system consisting of the Model 3537 Controller, the Model 3531 Verify External Neurostimulator (ENS), and associated cables (Models 3575 and 3576) and accessories.
P970004/S153
4/15/14
180-Day
InterStim Therapy for Urinary Control Medtronic Minneapolis, MN 55432 Approval for labeling updates to incorporate the long-term data from the fecal incontinence post-approval study into the InterStim® Therapy labeling.
P970013/S050
4/10/14
180-Day
Microny Family of Pacemakers St. Jude Medical Sylmar, CA
91342
Approval for the Merlin Conduct Mobile Software Application and Model 3330 version 16.1 software for the Model 3650 Merlin Patient Care System for the devices.
P970018/S028
4/28/14
180-Day
BD PREPSTAIN SYSTEM BD Diagnostic Systems
Durham, NC
27703
Approval for the BD PrepMate™ Automated Accessory with the upgraded control electronics to comply with current technologies.
P970021/S041
4/9/14
180-Day
GYNECARE THERMACHOICE Uterine Balloon Therapy System Ethicon, Inc.
Somerville, NJ 08876
Approval for the manufacturing site to be changed to CEA Medical Manufacturing, Inc., in Colorado Springs, Colorado.
P970051/S114
4/15/14
Real-Time
Nucleus Cochlear Implant System Cochlear Americas
Centennial, CO 80111
Approval for marketing an accessory, the Aqua+, for use with the Nucleus 5 CP810 and Nucleus 6 CP910/CP920 sound processors, which are currently approved for use with the cochlear implant system.
P980016/S398
4/23/14
180-Day
Virtuoso DR, Virtuoso VR, Secura DR, Maximo II DR Cardiac
Resynchronization Therapy
Medtronic, Inc.
Mounds View, MN 55112
Approval for a manufacturing site located at Plexus (Hangzhou) Co., Ltd., in Hangzhou, Zhejiang, China.
P980016/S458
4/11/14
135-Day
Maximo, Protecta, Secura, Virtuoso ICDs Medtronic, Inc.
Mounds View, MN 55112
Approval for updates to the hybrid test process.
P980016/S468
4/24/14
Real-Time
MARQUIS, MAXIMO Medtronic, Inc.
Mounds View, MN 55112
Approval for six software device applications on the Encore Programmer Model 29901.
P980040/S044
4/14/14
180-Day
Tecnis Toric 1-Piece Intraocular Lens Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Approval of the post-approval study protocol.
P980040/S046
4/28/14
180-Day
TECNIS® Multifocal 1-Piece Intraocular Lens with TECNIS iTec Preloaded Delivery System Abbott Medical Optics, Inc.
Santa Ana, CA 92705
Approval for a change in the packaging/delivery system for the TECNIS® Multifocal 1-Piece Intraocular Lens, Model ZMB00. The TECNIS® Multifocal 1-Piece Intraocular Lens in the new packaging/ delivery system is designated the TECNIS iTec Preloaded Delivery System, Model PMB00, and is indicated for primary implantation for the visual correction of aphakia in adult patients with and without presbyopia in whom a cataractous lens has been removed by phacoemulsification and who desire near, intermediate, and distance vision with increased spectacle independence. The intraocular lens is intended to be placed in the capsular bag.
P980049/S093
4/9/14
Real-Time
Paradym VR; Paradym DR; Paradym RF VR; Paradym RF DR  ICDs Sorin CRM USA
Arvada, CO
80004
Approval for minor design changes to the SRAM and Zener Diodes for the devices.
P980049/S094
4/17/14
Real-Time
Paradym VR; Paradym DR; Paradym RF VR;
Paradym RF DR
ICDs
Sorin CRM USA
Arvada, CO
80004
Approval for design changes to the setscrews and torque screwdriver used in connecting the leads to implantable defibrillators.
P990081/S027
4/9/14
Real-Time
PATHWAY Anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for addition of a Current Sense Printed Circuit Board (PCB) to the BenchMark ULTRA instrument that will prevent an overcurrent situation.
P000046/S023
4/10/14
180-Day
StaarviscII, Shellgel, NuVisc Sodium Hyaluronate Anika Therapeutics, Inc.
Bedford, MA
01730
Approval for a new trade name. The device, as modified, will be marketed under the trade name NuVisc™ and is indicated for use during surgery in the anterior and posterior segments of the human eye. Procedures include: cataract extraction, intraocular lens (IOL) implantation, corneal transplantation surgery, glaucoma filtering surgery, and surgical procedures to reattach the retina.
P010012/S341
4/11/14
180-Day
DYNAGEN, INOGEN, and ORIGEN Family of CRT-Ds; COGNIS/ TELIGEN Family of CRT-Ds; INCEPTA/ ENERGEN/
PUNCTUA family of CRT-Ds
Model 2868 Programmer Application Software
Boston Scientific Corporation
St. Paul, MN
55112
Approval for the following changes:
1) New pulse generator models listed above and modifications to the Model 2868 Programmer Application Software used to communicate with the new devices and existing devices; and
2)  Model 3140 ZOOM Wireless Transmitter and associated modifications to the Model 3120 PRM software.
P010012/S345
4/24/14
Real-Time
ACUITY Spiral, EASYTRAK 2, EASYTRAK 3 Leads Boston Scientific
St. Paul, MN
55112
Approval for a new outer sales box and closure labels for the leads.
P010013/S047
4/25/14
180-Day
Novasure Impedance Controlled Endometrial Ablation System Hologic, Inc.
Marlborough, MA 01752
Approval for decreased outer sheath diameter, modification of the cervical seal design, and change in the front handle color.
P010013/S051
4/22/14
180-Day
NovaSure Impedance Controlled Endometrial Ablation Device Hologic, Inc.
Marlborough, MA 01752
Approval for a change to the NovaSure Radiofrequency Controller (RFC) to incorporate a software-based graphical user interface (GUI), resulting in the Model 10 RFC.
P010015/S205
4/10/14
Panel-Track
Consulta® CRT-P;
Syncra® CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Approval for the expansion of the indications for use of the CRT-P and CRT-D devices to include NYHA Functional Class I, II, or III patients who have a left ventricular ejection fraction (LVEF) ≤ 50% are on stable, optimal heart failure medical therapy if indicated, and have atrioventricular block (AV block) that is expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. These devices are indicated for the following:  The Consulta CRT-P system is indicated for: 1)  NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal heart failure medical therapy and have a LVEF ≤ 35%  and a prolonged QRS duration; and
2) NYHA Functional Class I, II, or III patients who have a LVEF ≤ 50% are on stable optimal heart failure medical therapy if indicated and have atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant.  Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity.  Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.  Antitachycardia pacing (ATP) is indicated for termination of atrial tachyarrythmias in patients with one or more of the above pacing indications.  The Syncra CRT-P system is indicated for:  1)  NYHA Functional Class III and IV patients who remain symptomatic despite stable, optimal heart failure medical therapy and have a LVEF ≤ 35% and a prolonged QRS duration; and  2)  NYHA Functional Class I, II, or III patients who have a LVEF ≤ 50% are on stable, optimal heart failure medical therapy if indicated and have atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant.  Rate adaptive pacing is provided for those patients developing a bradycardia indication who might benefit from increased pacing rates concurrent with increases in activity.  Dual chamber and atrial tracking modes are indicated for patients who may benefit from maintenance of AV synchrony.
P010031/S361
4/23/14
180-Day
Consulta CRT-D; Concerto II CRT-D; Maximo II CRT-D Cardiac
Resynchronization Therapy
Medtronic, Inc.
Mounds View, MN 55112
Approval for a manufacturing site located at Plexus (Hangzhou) Co., Ltd., in Hangzhou, Zhejiang, China.
P010031/S381
4/10/14
Panel-Track
Consulta® CRT-D;
Maximo® II
CRT-D; Concerto® II CRT- D;
Protecta® CRT-D;
Protecta® XT CRT-D; Viva™ XT
CRT-D; Viva™ S CRT-D; Brava™ CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Approval for the expansion of the indications for use of the CRT-P and CRT-D devices to include NYHA Functional Class I, II, or III patients who have a left ventricular ejection fraction (LVEF) ≤ 50% are on stable, optimal heart failure medical therapy if indicated, and have atrioventricular block (AV block) that is expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. These devices are indicated For the Consulta CRT-D Model D224TRK, Concerto II CRT-D Model D274TRK, Consulta CRT-D Model D204TRM, Protecta XT CRT-D Model D314TRM, Protecta CRT-D Model D334TRM, Protecta XT CRT-D Model D314TRG, Protecta CRT-D Model D334TRG, Viva XT CRT-D Model DTBA1D4, Viva XT CRT-D Model DTBA1D1, Viva S CRT-D Model DTBB1D4, and Viva S CRT-D Model DTBB1D1:  The CRT-D system is indicated for patients who require ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias, for use in patients with atrial tachyarrhythmias, or those patients who are at significant risk for developing atrial tachyarrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following classifications:
1) New York Heart Association (NYHA) Functional Class III or IV and who have a left ventricular ejection fraction ≤ 35% and a prolonged QRS duration;
2) Left Bundle branch block (LBBB) with a QRS duration ≥ 130 ms, left ventricular ejection fraction ≤ 30% and NYHA Functional Class II; and 3)  NYHA Functional Class I, II, or III and who have left ventricular ejecton fraction ≤ 50% and atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant.  For the Maximo II CRT-D Model D284TRK, Maximo II CRT-D Model D264TRM, Brava CRT-D Model DTBC1D1 and Brava CRT-D Model DTBC1D4:  The CRT-D system is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias and for providing cardiac resynchronization therapy in heart failure patients on stable, optimal heart failure medical therapy if indicated, and meet any of the following classifications: 
1) New York Heart Association (NYHA) Functional Class III or IV and who have a left ventricular ejection fraction ≤ 25% and a prolonged QRS duration;
2) Left bundle branch block (LBBB) with a QRS duration ≥ 130 ms, left ventricular ejection fraction ≤ 30%, and NYHA Functional Class II; 3)  NYHA Functional Class I, II, III and who have left ventricular ejection fraction ≤ 50% and atrioventricular block (AV block) that are expected to require a high percentage of ventricular pacing that cannot be managed with algorithms to minimize right ventricular pacing. Optimization of heart failure medical therapy that is limited due to AV block or the urgent need for pacing should be done post implant.
P010031/S420
4/11/14
135-Day
Concerto, Consulta, Maximo, Protecta CRT-Ds Medtronic, Inc.
Mounds View, MN 55112
Approval to remove the use of the Sonoscan to detect four types of delamination at internal supplier.
P010032/S073
4/25/14
180-Day
Eon Mini Implantable Pulse Generator (IPG) Neurostimulation System St. Jude Medical
Plano, TX
75024
Approval for a manufacturing site located at St. Jude Medical Puerto Rico LLC, in Arecibo, Puerto Rico.
P010032/S076
4/25/14
Real-Time
EonC™ IPG Neurostimulation System; Eon™ IPG Neurostimulation System; Eon Mini™ IPG Neurostimulation System; Tripole™ 16C Leads; Tripole™ 16 Leads;
Exclaim™ Leads; Lamitrode™ 4 Leads; Lamitrode™ 44 Leads; Lamitrode™ 44C Leads; Lamitrode™ S-4 Leads; Lamitrode™ S-8 Leads; Lamitrode™ 88 Leads; Penta™ Leads; Quattrode™ Leads; Octrode™ Leads
St. Jude Medical
Plano, TX
75024
Approval for packaging modifications to remove the Model 3009 Trial Cable from approved SJM Leads and extensions.
P020002/S007
4/29/14
Real-Time
ThinPrep® Imaging System Hologic, Inc.
Marlborough, MA 01752
Approval for the introduction of the ThinPrep® Imager Duo Imaging Station, hardware (camera and exterior housing) changes, and associated software changes.
P020018/S050
4/2/14
180-Day
The Zenith Fenestrated AAA Endovascular Graft Cook, Inc.
Bloomington, IN 47402
Approval of the post-approval study protocol.
P020050/S015
4/10/14
Real-Time
WaveLight® EX500 Excimer Laser System Alcon Research, Ltd.
Fort Worth, TX 76134
Approval for an alternate modified patient swivel bed for use with the WaveLight® EX500 Excimer Laser System. The modifications allow the patient bed to be used with femtosecond lasers other than the WaveLight FS200 laser to create the flap for laser-assisted in situ keratomileusis (LASIK).
P030008/S013
4/10/14
Real-Time
WaveLight® EX500 Excimer Laser System Alcon Research, Ltd.
Fort Worth, TX 76134
Approval for an alternate modified patient swivel bed for use with the WaveLight® EX500 Excimer Laser System. The modifications allow the patient bed to be used with femtosecond lasers other than the WaveLight FS200 laser to create the flap for laser-assisted in situ keratomileusis (LASIK).
P030019/S018
4/30/14
135-Day
Orthovisc High Molecular Weight Hyaluronan Anika Therapeutics, Inc.
Bedford, MA
01730
Approval for the addition of an alternative supplier for materials.
P030035/S098
4/10/14
180-Day
Frontier/Frontier II/ Anthem Family of CRT-Ps St. Jude Medical Sylmar, CA
91342
Approval for the Merlin Conduct Mobile Software Application and Model 3330 version 16.1 software for the Model 3650 Merlin Patient Care System for the devices.
P030050/S016
4/23/14
180-Day
Sculptra Aesthetic Valeant Pharmaceuticals
Bridgewater, NJ 08807
Approval of the post-approval study protocol.
P030053/S017
4/18/14
180-Day
MemoryGel Silicone Gel-Filled Breast Implants Mentor Worldwide, LLC
Santa Barbara, CA 93111
Approval of the post-approval study protocol.
P030054/S226
4/10/14
180-Day
Epic HF/Atlas+ HF/Quadra Assura/Unify Assura Family of CRT-Ds St. Jude Medical Sylmar, CA
91342
Approval for the Merlin Conduct Mobile Software Application and Model 3330 version 16.1 software for the Model 3650 Merlin Patient Care System for the devices.
P040014/S022
4/28/14
Real-Time
Therapy Ablation Catheters St. Jude Medical
St. Paul, MN
55117
Approval for changes to thermal and EGM boards, upgrade to the firmware and software, addition of remote control fiber cord lengths and updates to the instructions for use of the Ampere generator.
P040020/S048
4/28/14
180-Day
AcrySof® ReSTOR® IOLs Alcon Laboratories, Inc.
Fort Worth, TX 76134
Approval for three alternate polypropylene materials, Basell PD702, Exxon Achieve 1605, and Exxon PP1105E1, for intraocular lens (IOL) device primary packaging.
P040037/S062
4/2/14
Real-Time
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with Heparin Bioactive Surface W.L. Gore & Associates
Flagstaff, AZ
86005
Approval for the addition of radiopaque markers to the endoprosthesis and a revised end tape.
P040042/S027
4/28/14
Real-Time
Therapy Dual 8, Therapy 8mm Thermistor, and Safire TX Ablation Catheters, and
RF Generators
St. Jude Medical
St. Paul, MN
55117
Approval for changes to thermal and EGM boards, upgrade to the firmware and software, addition of remote control fiber cord lengths and updates to the instructions for use of the Ampere generator.
P050016/S010
4/3/14
Real-Time
Cormet Hip Resurfacing System Corin USA
Tampa, Florida 33607
Approval for an addition to the labeling for the Cormet Hip Resurfacing System to include MR Conditional language in the Warnings and Precautions for the system.
P050046/S023
4/24/14
Real-Time
ACUITY Steerable Leads Boston Scientific
St. Paul, MN
55112
Approval for a new outer sales box and closure labels for the leads.
P050047/S033
4/17/14
135-Day
JUVÉDERM XC Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Approval for a change to the quality control testing method used to confirm the concentration of lidocaine and lidocaine degredants in JUVÉDERM Hyaluronate Gel Implants.
P060019/S027
4/28/14
Real-Time
Therapy Cool Path, Safire BLU, Safire BLU SP, and Therapy Cool Path SP Ablation
Catheters, and Generators
St. Jude Medical
St. Paul, MN
55117
Approval for changes to thermal and EGM boards, upgrade to the firmware and software, addition of remote control fiber cord lengths and updates to the instruction for use of the Ampere generator.
P060027/S060
4/9/14
Real-Time
Paradym CRT-D; Paradym RF CRT-D Sorin CRM USA
Arvada, CO
80004
Approval for minor design changes to the SRAM and Zener Diodes for the devices.
P060027/S061
4/17/14
Real-Time
Paradym CRT-D;  Paradym RF
CRT-Ds
Sorin CRM USA
Arvada, CO
80004
Approval for design changes to the setscrews and torque screwdriver used in connecting the leads to implantable defibrillators.
P060038/S017
4/18/14
180-Day
Mitroflow Aortic Pericardial Heart Valve Sorin Group USA, Inc.
Arvada, CO
80004
Approval for manufacturing process changes to the Mitroflow Aortic Pericardial Heart Valve, Model LX, consisting of implementation of the Phospholipid Reduction Treatment manufacturing process (an anticalcification treatment process). The device, as modified, will be marketed under the trade name Mitroflow Aortic Pericardial Heart Valve with Phospholipid Reduction Treatment, Model DL and is indicated for the replacement of diseased, damaged, or malfunctioning native or prosthetic aortic valves.
P060040/S033
4/3/14
Special
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA 94588
Approval for revisions to the Instructions for Use and the Patient Handbook.
P080014/S018
4/29/14
180-Day
Cervista® HPV HR and Genfind Kit Hologic, Inc.
Marlborough, MA 01752
Approval for a post approval study labeling update.
P080015/S009
4/29/14
180-Day
Cervista® HPV 16/18 Hologic, Inc.
Marlborough, MA 01752
Approval for a post approval study labeling update.
P080025/S046
4/18/14
180-Day
Medtronic InterStim Therapy for Bowel Control Medtronic Neuromodulation
Minneapolis, MN 55432
Approval for Medtronic’s Verify™ Evaluation System, which is a test stimulation system consisting of the Model 3537 Controller, the Model 3531 Verify External Neurostimulator (ENS), and associated cables (Models 3575 and 3576) and accessories.
P080025/S049
4/15/14
180-Day
InterStim Therapy for Bowel Control Medtronic Minneapolis, MN 55432 Approval for labeling updates to incorporate the long-term data from the fecal incontinence post-approval study into the InterStim® Therapy labeling.
P090013/S32
4/24/14
Real-Time
ENRHYTHM MRI, REVO MRI Medtronic, Inc.
Mounds View, MN 55112
Approval for six software device applications on the Encore Programmer Model 29901.
P090016/S008
4/10/14
Real-Time
Belotero Balance® Merz North America Incorporated
Franksville, WI 53126
Approval for a change to the tip cap material.
P100020/S008
4/24/14
Panel-Track
cobas® HPV Test Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Approval for the cobas® HPV Test. cobas® HPV Test Indications for Use: The cobas® HPV Test is a qualitative in vitro test for the detection of Human Papillomavirus in cervical specimens collected by a clinician using an endocervical brush/spatula and placed in the ThinPrep® Pap TestTM PreservCyt® Solution. The test utilizes amplification of target DNA by the Polymerase Chain Reaction (PCR) and nucleic acid hybridization for the detection of 14 high-risk (HR) HPV types in a single analysis. The test specifically identifies types HPV16 and HPV18 while concurrently detecting the rest of the high risk types (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66 and 68). The cobas® HPV Test is indicated:
1) To screen patients 21 years and older with ASC-US (atypical squamous cells of undetermined significance) cervical cytology test results to determine the need for referral to colposcopy;
2) To be used in patients 21 years and older with ASC-US cervical cytology results, to detect high-risk HPV genotypes 16 and 18. This information, together with the physician’s assessment of screening history, other risk factors, and professional guidelines, may be used to guide patient management. The results of this test are not intended to prevent women from proceeding to colposcopy;
3) In women 30 years and older, the cobas® HPV Test can be used with cervical cytology to adjunctively screen to detect high risk HPV types. This information, together with the physician’s assessment of screening history, other risk factors, and professional guidelines, may be used to guide patient management;
4) In women 30 years and older, the cobas® HPV Test can be used to detect HPV genotypes 16 and 18. This information, together with the physician’s assessment of screening history, other risk factors, and professional guidelines, may be used to guide patient management.
5. In women 25 years and older, the cobas® HPV Test can be used as a first‐line primary cervical cancer screening test to detect high risk HPV, including genotyping for 16 and 18.  Women who test negative for high risk HPV types by the cobas® HPV Test should be followed up in accordance with the physician’s assessment of screening and medical history, other risk factors, and professional guidelines. Women who test positive for HPV genotypes 16 and/or 18 by the cobas® HPV Test should be referred to colposcopy.  Women who test high risk HPV positive and 16/18 negative by the cobas® HPV Test (12 other HR HPV positive) should be evaluated by cervical cytology to determine the need for referral to colposcopy.
P100025/S005
4/18/14
180-Day
BreathTek® UBT for H. pylori and pUHR-CA Otsuka America Pharmaceutical
Rockville, MD 20850
Approval for the addition of the POCone Infrared Spectrophotometer for pediatric use.
P100027/S016
4/9/14
Real-Time
INFORM HER2 Dual ISH DNA Probe Cocktail Ventana Medical Systems, Inc.
Tucson, AZ
85755
Approval for addition of a Current Sense Printed Circuit Board (PCB) to the BenchMark ULTRA instrument that will prevent an overcurrent situation.
P100040/S017
4/30/14
Real-Time
Valiant Thoracic Stent Graft System with Captivia Delivery System Medtronic Vascular
Santa Rosa, CA 95403
Approval for the addition of the FreeFlo Tapared stent-grafts to the list of devices indicated for treating thoracic aortic dissections,
P100042/S002
4/29/14
Real-Time
Aptima HPV Assay Hologic Gen-Probe Incorporated
San Diego, CA 92121
Approval for the minor software changes for the Aptima HPV Assay Software (v2.3.5), the Aptima HPV-GT Assay Software (v2.7.5), Panther System Software (v5.2).
P100047/S035
4/10/14
180-Day
HeartWare® Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Approval for a new material for the electrical cable outer jacket and connector boot of the Driveline Extension cable.
P110014/S001
4/29/14
180-Day
MarginProbe System Dune Medical Devices, Inc.
Framingham, MA
0701
Approval of the post-approval study protocol.
P110016/S011
4/28/14
Real-Time
Therapy Cool Path Duo, Safire BLU Duo, Cool Path Duo, Safire Duo, Therapy Cool Path
Duo SP, Safire BLU Duo SP and Therapy Cool Flex Ablation Catheters, and RF Generators
St. Jude Medical
St. Paul, MN
55117
Approval for changes to thermal and EGM boards, upgrade to the firmware and software, addition of remote control fiber cord lengths and updates to the instructions for use of the Ampere generator.
P110019/S047
4/23/14
Real-Time
XIENCE Xpedition, XIENCE Xpedition Small Vessel (SV) and XIENCE Xpedition Long Lesion (LL) Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA 92589
Approval for an update to the labeling for the XIENCE Xpedition RX (rapid exchange) and OTW (over-the-wire) to change the guiding catheter compatibility for the 4.0mm balloon diameter sizes from a minimum of a 6 French (F) guide catheter to 5F for the 4.0 x 8-33mm sizes.
P110042/S017
4/2/14
180-Day
Subcutaneous Implantable Defibrillator (S-ICD) System Boston Scientific Corporation
St. Paul, MN
55112
Approval for a manufacturing site located at Cameron Health, Inc., a subsidiary of Boston Scientific Corporation, in Tipperary, Ireland.
P120006/S009
4/23/14
180-Day
Ovation and Ovation Prime Abdominal Stent Graft Systems TriVascular, Inc.
Santa Rosa, CA 95403
Approval for a change to the Indication for Use for the Ovation and Ovation Prime Abdominal Stent Graft Systems by clarifying that percutaneous access and femoral cutdown are appropriate vascular access techniques. The device, the TriVascular Ovation and Ovation Prime Abdominal Stent Graft System, is indicated for treatment of patients with abdominal aortic aneurysms having the vascular morphology suitable for endovascular repair, including:
1) Adequate iliac/femoral access compatible with vascular access techniques (femoral cutdown or percutaneous), devices, and/or accessories;
2) Proximal aortic landing zone:
a) with an inner wall diameter of no less than 16 mm and no greater than 30 mm at 13 mm below the inferior renal artery; and b) with an aortic angle of ≤ 60 degrees if proximal neck is ≥ 10 mm and ≤ 45 degrees if proximal neck is <10 mm; and
3) Distal iliac landing zone:
a) with a length of at least 10 mm; and
b) with an inner wall diameter of no less than 8 mm and no greater than 20 mm.
P120007/S002
4/29/14
Real-Time
Aptima HPV 16 18/45 Genotype Assay Hologic Gen-Probe Incorporated
San Diego, CA 92121
Approval for the minor software changes for the Aptima HPV Assay Software (v2.3.5), the Aptima HPV-GT Assay Software (v2.7.5), Panther System Software (v5.2).
P120020/S001
4/30/14
180-Day
Supera Peripheral Stent System Abbott Vascular
Santa Clara, CA 95054
Approval for a manufacturing site located at Sterigenics in Los Angeles, California.
P130006/S001
4/10/14
Real-Time
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with
Heparin Bioactive Surface
W.L. Gore & Associates
Flagstaff, AZ
86005
Approval for revised specification limits for manufacturing aids.
P130006/S002
4/10/14
Real-Time
GORE® VIABAHN® Endoprosthesis and GORE® VIABAHN® Endoprosthesis with
Heparin Bioactive Surface
W.L. Gore & Associates
Flagstaff, AZ
86005
Approval for adding radiopaque markers to the endoprosthesis.
P130021/S003
4/3/14
Special
Medtronic CoreValve System Medtronic CoreValve, LLC
Santa Rosa, CA 95403
Approval for modifications to the labeling to clarify the indications for use and the instructions for post-implantation dilatation.

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
N18286/S026
4/9/14
GELFOAM (absorbable gelatin) Sterile Sponge Pfizer, Inc.
New York, NY 10017
Changes to the 10 mL pre-filled 0.9% sodium chloride solution syringe, packaged within the Gelfoam Plus Hemostasis Kits.
P810006/S051
4/28/14
Collastat, Instat Absorbable Collagen Hemostatic Agents Integra Lifesciences Corporation
Plainsboro, NJ 08536
Enhancements for the Lyophilizer Chamber Vacuum Control.
P840001/S263
4/4/14
SCS Extensions;
Hinged 2x4 Surgical Lead; Specify Lead
Medtronic, Inc.
Minneapolis, MN 55432
Relocate the manufacturing facility of an external supplier.
P840001/S264
4/9/14
SureScan MRI Implantable Neurostimulators Medtronic, Inc.
Minneapolis, MN 55432
Change the sub-tier supplier for a component.
P840001/S265
4/10/14
SCS Neurostimulators Implantable Itrel Family; SCS Neurostimulators Implantable Restore Family Medtronic, Inc.
Minneapolis, MN 55432
Changes to the copper etching process on the printed wiring board substrates.
P840001/S266
4/24/14
SCS Implantable Neurostimulators (Itrel, Restore and Synergy); SCS Accessories; SCS Leads; SCS Extensions; SCS Programming Systems; SCS Recharging System; and SCS Screening Trialing Systems Medtronic, Inc.
Minneapolis, MN 55432
Update the software used at several Medtronic’s manufacturing facilities.
P840062/S038
4/28/14
CollaCote, CollaTape, and CollaPlug Absorbable Collagen Wound Dressings for Dental
Surgery
Integra Lifesciences Corporation
Plainsboro, NJ 08536
Enhancements for the Lyophilizer Chamber Vacuum Control.
P840064/S056
4/29/14
Viscoat, Duovisc, and Discovisc Ophthalmic Viscosurgical Devices (OVD) Alcon Research, Ltd.
Fort Worth, TX 76134
Use of a new raw material in the rubber formulation of the tip caps used for their Viscoat, Duovisc, Discovisc, and Provisc OVD. Also, a material addition to optimize the placement of the tip cap for the Viscoat.
P850010/S050
4/23/14
Absorbable Collagen Hemostatic Agents Integra LifeSciences Corporation
Plainsboro, NJ 08536
Qualification of a sealing tool for use on the Alloyd heat seal machine.
P850010/S051
4/28/14
Helistat, Helitene
Absorbable Collagen Hemostatic Agents
Integra
Plainsboro, NJ 08536
Enhancements for the Lyophilizer Chamber Vacuum Control.
P860004/S203
4/10/14
Drug Delivery for CRDH PAH Infusion Pumps SynchroMed Family Medtronic, Inc.
Minneapolis, MN 55432
Changes to the copper etching process on the printed wiring board substrates.
P860004/S204
4/24/14
Drug Delivery Infusion Pumps SynchroMed; Drug Delivery Accessories; Drug Delivery Catheters; Drug Delivery Kits for Revisions; and Drug Delivery Programming Systems Medtronic, Inc.
Minneapolis, MN 55432
Update the software used at several Medtronic’s manufacturing facilities.
P860057/S122
4/30/14
Carpentier-Edwards PERIMOUNT Bioprosthesis Edwards Lifesciences, LLC
Irvine, CA
92614
Addition of an alternate wireforming machine.
P880086/S240
4/4/14
Assurity, Assurity+, and Endurity Family of Pacemakers St. Jude Medical CRDM
Sylmar, CA
91342
Alternate Burn-In (BI) for the environmental screening used during the manufacture of the devices.
P880086/S241
4/24/14
Assurity, Assurity +, Endurity St. Jude Medical CRDM
Sylmar, CA
91342
Alternate final assembly material for use in hybrid assemblies.
P890047/S043
4/29/14
Provisc Ophthalmic Viscosurgical Devices (OVD) Alcon Research, Ltd.
Fort Worth, TX 76134
Use of a new raw material in the rubber formulation of the tip caps used for their Viscoat, Duovisc, Discovisc, and Provisc OVD. Also, a material addition to optimize the placement of the tip cap for the Viscoat.
P900056/S134
4/17/14
Rotablator Rotational Atherectomy System Boston Scientific, Corp.
Maple Grove, MN 55311
New vendor for the RotaLink brake spring utilized in the Rotablator Advancer, a component of the Rotablator Atherectomy System.
P900056/S135
4/23/14
Rotablator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P900056/S136
4/24/14
Rotablator Rotational Atherectomy System Boston Scientific Corporation
Maple Grove, MN 55311
Addition of an alternate microbiology laboratory for the testing of bioburden for the Rotawire with Wire Clip Torquer.
P910001/S070
4/17/14
Excimer Laser Coronary Atherectomy (ELCA) Catheters Spectranetics, Corp.
Colorado Springs, CO
80921
Change to establish the operating range within which the Fiber Winder can spool fiber for the SLS and ELCA product lines.
P910056/S016
4/25/14
Envista IOLs Bausch and Lomb, Inc.
Irvine, CA
92618
Addition of a manufacturing cleanroom, ISO Class 7 at the Clearwater, Florida facility.
P920047/S067
4/4/14
Blazer II, Blazer II HTD, Blazer Prime HTD Temperature Ablation
Catheters
Boston Scientific
San Jose, CA
95134
Acceptance for bioburden testing to be completed at an alternate facility.
P920047/S068
4/23/14
Blazer II Cardiac Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P950029/S090
4/21/14
Reply SR/DR, Esprit SR/DR Pacemakers Sorin CRM
Arvada, CO
80004
Changes to in-process verifications on the electronic assembly line.
P950039/S028
4/24/14
ThinPrep Processor 2000/3000 Hologic, Inc.
Marlborough, MA 01752
Addition of a new raw material supplier for float glass used to manufacture the ThinPrep Pap Test microscope slide.
P960009/S190
4/4/14
DBS Extensions Medtronic, Inc.
Minneapolis, MN 55432
Relocate the manufacturing facility of an external supplier.
P960009/S191
4/10/14
DBS Neurostimulators Implantable Activa Family Medtronic, Inc.
Minneapolis, MN 55432
Changes to the copper etching process on the printed wiring board substrates.
P960009/S192
4/24/14
DBS Implantable Neurostimulators (Activa, Kinetra and Soletra); DBS Accessories; DBS Extensions; DBS Leads; DBS Programming Systems; DBS Recharging Systems; and DBS Screening Systems Medtronic, Inc.
Minneapolis, MN 55432
Update the software used at several Medtronic’s manufacturing facilities.
P960042/S048
4/17/14
Spectranetics Laser Sheaths (SLSII and GlideLight) Spectranetics, Corp.
Colorado Springs, CO
80921
Change to establish the operating range within which the Fiber Winder can spool fiber for the SLS and ELCA product lines.
P960043/S088
4/17/14
Perclose ProGlide Suture Mediated Closure Device;
Perclose AT 6F Suture Mediated Closure System;
Prostar XL 10F Percutaneous Vascular Surgical System
Abbott Vascular, Inc.
Santa Clara, CA 95054
Alternate supplier for several extruded components used to manufacture the devices.
N970003/S161
4/29/14
ADVANTIO, INGENIO, VITALIO, and FORMIO families of Pacemakers Boston Scientific Corporation
St. Paul, MN
55112
Add an alternate source supplier for tantalum capacitors.
P970004/S168
4/2/14
Sacral Nerve Stimulation (SNS), Urinary Implantable Neurostimulator (INS) Interstim Family Medtronic Neuromodulation
Minneapolis, MN 55432
Qualification of two alternative suppliers for a silicone component.
P970004/S169
4/11/14
Sacral Nerve Stimulation (SNS), Urinary Implantable Neurostimulator (INS) Interstim Family Medtronic Neuromodulation
Minneapolis,  MN 55432
Additional in-process inspections and tooling changes in the manufacturing process of a component of the InterStim II Neurostimulator, at the Medtronic Energy and Component Center.
P970004/S170
4/10/14
SNS Urinary Neurostimulator Implantable InterStim Family Medtronic, Inc.
Minneapolis, MN 55432
Changes to the copper etching process on the printed wiring board substrates.
P970004/S171
4/24/14
SNS Urinary Implantable Neurostimulators (InterStim); SNS Urinary Accessories; SNS Urinary Extensions; SNS Urinary Leads; SNS Urinary Programming Systems; and SNS Urinary Screening Trialing Systems Medtronic, Inc.
Minneapolis, MN 55432
Update the software used at several Medtronic’s manufacturing facilities.
P970020/S079
4/8/14
MULTILINK ULTRA RX and OTW Coronary Stent Systems Abbott Vascular
Temecula, CA 92591
Change to the laser cutting equipment for the stent sub-assembly manufacturing process.
P970051/S118
4/25/14
Nucleus 24 Cochlear Implant System Cochlear Americas
Centennial, CO 80111
Acceptance of a supplier manufacturing process change.
P980003/S048
4/23/14
Chilli II Cooled Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P980016/S470
4/4/14
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
Manufacturing process change for the printed wiring board (PWB) substrates at a Medtronic second tier supplier. These PWB substrates are used in the manufacture of hybrid substrates at Medtronic’s internal supplier, Medtronic Tempe Campus (MTC), for the devices.
P980016/S471
4/2/14
Maximo, Protecta, Secura, Virtuoso II DR/VR ICDs Medtronic, Inc.
Mounds View, MN 55112
Use of a Joining Data Collection (JDC) Application in their manufacturing process application.
P980016/S473
4/4/14
Evera S DR ICD; Evera S VR ICD; Evera XT DR ICD; Evera XT VR ICD Medtronic, Inc.
Mounds View, MN 55112
Additional leak check testers, and the software updates for the device’s capacitors.
P980016/S475
4/15/14
MAXIMO II, PROTECTA, PROTECTA XT, SECURA, VIRTUOSO II,
EVERA S AND EVERA XT IMPLANTABLE CARDIOVERTER
DEFIBRILLATORS (ICD)
Medtronic, Inc.
Mounds View, MN 55112
New equipment in the final packaging lines at the Medtronic Puerto Rico Operations Company.
P980016/S476
4/10/14
Evera S DR/VR ICD, Evera XT DR/VR ICD Medtronic, Inc.
Mounds View, MN 55112
Change to the in-process inspection criteria for battery cells for the devices.
P980035/S368
4/4/14
Adapta, Versa, Sensia IPG; Advisa DR IPG; Advisa DR MRI IPG Relia IPG Medtronic, Inc.
Mounds View, MN 55112
Manufacturing process change for the printed wiring board (PWB) substrates at a Medtronic second tier supplier. These PWB substrates are used in the manufacture of hybrid substrates at Medtronic’s internal supplier, Medtronic Tempe Campus (MTC), for the devices.
P980035/S370
4/15/14
ADAPTA, VERSA, SENSIA, ADVISA, AND ADVISA MRI
IMPLANTABLE PULSE GENERATORS (IPG)
Medtronic, Inc.
Mounds View, MN 55112
New equipment in the final packaging lines at the Medtronic Puerto Rico Operations Company.
P980035/S371
4/11/14
Adapta, Versa, Sensia, Relia IPG Medtronic, Inc.
Mounds View, MN 55112
Addition of an automated electrical tester at supplier (Meggitt) for the  devices.
P980049/S095
4/16/14
Paradym RF VR; Paradym RF DR; and Paradym RF CRT-D Sorin CRM USA, Inc
Arvada, CO
80004
Changes for the devices (platform ZL102):
1) Added equipment cooler stacker/de-stacker used in the electronic SMD assembly line;
2) Laser welding process rework for visual defect on case; and
3. Paradym RF (ZL102), in sourcing of RF module manufacturing
P980049/S096
4/21/14
Paradym VR/DR, Paradym RF VR/DR ICDs Sorin CRM
Arvada, CO
80004
Changes to in-process verifications on the electronic assembly line.
P000012/S048
4/7/14
COBAS® AMPLICOR® Hepatitis C Virus version 2.0 and COBAS® AmpliPrep/
COBAS® AMPLICOR® HCV Test version 2.0
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Addition of a new supplier for a system component used in the manufacture of the COBAS AmpliPrep Instrument.
P000012/S049
4/28/14
COBAS® AMPLICOR® Hepatitis C Virus Test version 2.0 and COBAS® AmpliPrep/ COBAS® AMPLICOR® HCV Test version 2.0 Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Addition of a new supplier for subassemblies in the manufacture of the COBAS® AmpliPrep Instrument.
P010015/S235
4/4/14
Consulta CRT-P; Syncra CRT-P Medtronic, Inc.
Mounds View, MN 55112
Manufacturing process change for the printed wiring board (PWB) substrates at a Medtronic second tier supplier. These PWB substrates are used in the manufacture of hybrid substrates at Medtronic’s internal supplier, Medtronic Tempe Campus (MTC), for the devices.
P010031/S431
4/4/14
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
Manufacturing process change for the printed wiring board (PWB) substrates at a Medtronic second tier supplier. These PWB substrates are used in the manufacture of hybrid substrates at Medtronic’s internal supplier, Medtronic Tempe Campus (MTC), for the devices.
P010031/S432
4/2/14
Consulta ICD and Concerto II, Maximo II, Protecta CRT-Ds Medtronic, Inc.
Mounds View, MN 55112
Use of a Joining Data Collection (JDC) Application in their manufacturing process application.
P010031/S434
4/4/14
Brava CRT-D; Viva S CRT-D; Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
Additional leak check testers, and the software updates for the device’s capacitors.
P010031/S436
4/15/14
VIVA, BRAVA, CONCERTO II, CONSULTA, MAXIMO II,
PROTECTA, AND PROTECTA XT CARDIAC
RESYNCHRONI-ZATION THERAPY – DEFIBRILLATORS (CRT-D)
Medtronic, Inc.
Mounds View, MN 55112
New equipment in the final packaging lines at the Medtronic Puerto Rico Operations Company.
P010031/S437
4/10/14
Brava CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
Change to the in-process inspection criteria for battery cells for the devices.
P010032/S077
4/4/14
Eon Mini Neuromodulation Systems St Jude Medical
6901 Preston Road
Plano, TX
75024
Add a manufacturing specification for minimum electrode window cut out dimensions.
P020009/S120
4/23/14
Express2 Monorail and OTW Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P020009/S122
4/24/14
Express2® Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Implement changes that will optimize the resin drying process for the catheter manufacture.
P020025/S055
4/4/14
Blazer II XP, Blazer Prime XP, Intellatip MiFi XP Temperature Ablation
Catheters
Boston Scientific
San Jose, CA
95134
Acceptance for bioburden testing to be completed at an alternate facility.
P020025/S056
4/23/14
Blazer II XP Cardiac Ablation Catheter and Cable Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P020036/S026
4/16/14
SMART and SMART Control Nitinol Stent Systems Cordis Corp.
Fremont, CA
94555
Add an additional semi-automated inspection step to the current pouch sealing inspection.
P020047/S057
4/15/14
MULTI-LINK VISION® Coronary Stent System;
MULTI-LINK MINI VISION® Coronary Stent System;
MULTI-LINK 8® and MULTI-LINK 8® LL Coronary Stent Systems (CSS); MULTI-LINK 8® SV Coronary Stent System
Abbott Vascular
Temecula, CA 92589
Change to increase the speed at which the cobalt chromium-based stents are laser cut.
P030005/S108
4/29/14
INVIVE, INTUA Families of CRT-Ps Boston Scientific Corporation
St. Paul, MN
55112
Add an alternate source supplier for tantalum capacitors.
P030009/S076
4/17/14
Integrity Coronary Stent Systems Medtronic, Inc.
Santa Rosa, CA 95403
Changes and upgrades to the current electropolishing station.
P030017/S192
4/17/14
Precision Spectra™ Spinal Cord Stimulator (SCS) System Boston Scientific Corporation
Valencia, CA
91355
Update the test equipment software for testing the Printed Circuit Board Assembly (PCBA) of the Remote control (RC).
P030017/S193
4/21/14
Precision and Precision Spectra Spinal Cord Stimulator (SCS) Systems Boston Scientific Corporation
Valencia, CA
91355
Addition of a cleaning step to the cable manufacturing process.
P030035/S118
4/4/14
Allure and Allure Quadra Family of CRT-P Devices St. Jude Medical CRDM
Sylmar, CA
91342
Alternate Burn-In (BI) for the environmental screening used during the manufacture of the devices.
P030035/S119
4/24/14
Allure, Allure Quadra, Allure RF, Allure Quadra RF St. Jude Medical CRDM
Sylmar, CA
91342
Alternate final assembly material for use in hybrid assemblies.
P030050/S021
4/29/14
SCULPTRA and SCULPTRA AESTHETIC Valeant Pharmaceuticals North America LLC
Bridgewater, NJ 08807
Replacement of the motor for a hopper and subsequent requalification of that hopper at the  firm’s manufacturing facility.
P040016/S126
4/23/14
VeriFLEX (Liberté) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P040016/S128
4/24/14
VeriFLEX™ (Liberté®) Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Implement changes that will optimize the resin drying process for the catheter manufacture.
P040021/S025
4/2/14
Biocor™ and Epic™ Valve St. Jude Medical
St. Paul, MN
55117
Change to the incoming inspection plan for the polyester fabric component of the subject valves.
P040044/S051
4/24/14
Mynx Cadence Vascular Closure Device; MynxGrip® Vascular Closure Device; Mynx Ace™ Vascular Closure Device AccessClosure, Inc.
Mountain View, CA 94043
Implementation of a new frost fan fixture.
P040044/S052
4/30/14
Mynx Vascular Closure Device AccessClosure, Inc.
Mountain View, CA 94043
Reduction in the pouch seal sampling plan.
P040045/S043
4/10/14
VISTAKON
Senofilcon A Brand Contact Lenses
Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Addition of an alternate raw material supplier.
P040045/S044
4/29/14
VISTAKON
Senofilcon A Brand Contact Lenses
Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Change to the stent sub-assembly manufacturing equipment.
P050028/S041
4/7/14
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
Addition of a new supplier for a system component used in the manufacture of the COBAS AmpliPrep Instrument.
P050028/S042
4/28/14
COBAS® AmpliPrep/COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test Version 2.0 For Use With The High Pure System Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Addition of a new supplier for subassemblies in the manufacture of the COBAS® AmpliPrep Instrument.
P050042/S029
4/28/14
ARCHITECT Anti-HCV Abbott Laboratories Abbott Park, IL 60064 Addition of an alternate supplier for a material used in the manufacture of an ARCHITECT Anti-HCV component.
P050047/S036
4/14/14
Juvéderm Hyaluronate Gel Implants Allergan
Goleta, CA
93117
Changes to the ISO classification of the syringe drying, 100% visual inspection, syringe assembly and thermoformed tray packaging rooms.
P050051/S026
4/15/14
ARCHITECT AUSAB Abbott Laboratories,
Abbott Park, IL 60064
Addition of a newly constructed ISO Class 8 Dispensary Area for buffer preparation.
P060002/S035
4/23/14
Bard® FLAIR® Endovascular Stent Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
New measuring equipment for use in incoming quality control (IQC) inspections.
P060006/S058
4/23/14
Express SD Renal Monorail Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P060027/S062
4/16/14
Paradym RF VR; Paradym RF DR; and Paradym RF CRT-D Sorin CRM USA, Inc
Arvada, CO
80004
Changes for the devices (platform ZL102):
1) Added equipment cooler stacker/de-stacker used in the electronic SMD assembly line;
2) Laser welding process rework for visual defect on case; and
3. Paradym RF (ZL102), in sourcing of RF module manufacturing
P060027/S063
4/21/14
Paradym, Paradym RF CRT-Ds Sorin CRM
Arvada, CO
80004
Changes to in-process verifications on the electronic assembly line.
P060030/S041
4/7/14
COBAS® AmpliPrep/
COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Addition of a new supplier for a system component used in the manufacture of the COBAS AmpliPrep Instrument.
P060030/S042
4/28/14
COBAS® AmpliPrep/COBAS® TaqMan® HCV Test and
COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Addition of a new supplier for subassemblies in the manufacture of the COBAS® AmpliPrep Instrument.
P060033/S090
4/9/14
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System Medtronic, Inc.
Santa Rosa, CA 95403
Extension to the retest period for Zotarolimus from 12 months to 24 months.
P060033/S091
4/17/14
Endeavor Sprint Zotarolimus-Eluting Coronary Stent System Medtronic, Inc.
Santa Rosa, CA 95403
Changes and upgrades to the current electropolishing station.
P060039/S058
4/4/14
Attain StarFix Lead Medtronic CRDM
Mounds View MN, 55112
Alternate press machine at a supplier for the manufacture of the retention sleeve used with the Attain StarFix Lead.
P060040/S034
4/9/14
Thoratec HeartMate II Left Ventricular Assist System (LVAS) Thoratec Corporation
Pleasanton, CA 94588
Addition of a second supplier for the Emergency Backup Battery (EBB).
P070014/S043
4/23/14
Bard® LifeStent® Vascular Stent Systems Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
New measuring equipment for use in incoming quality control (IQC) inspections.
P070015/S121
4/15/14
XIENCE PRIME® Everolimus Eluting Coronary Stent System; XIENCE PRIME® Everolimus Eluting Coronary Stent System, LL;
XIENCE PRIME® Everolimus Eluting Coronary Stent System, SV;
XIENCE Xpedition® Everolimus Eluting Coronary Stent System
Abbott Vascular
Temecula, CA 92589
Change to increase the speed at which the cobalt chromium-based stents are laser cut.
P070027/S040
4/3/14
Talent Occluder with Occluder Delivery System Medtronic Vascular
Santa Rosa, CA 95403
Vendor location change.
P080007/S020
4/23/14
Bard® E-Luminexx® Vascular Stent Bard Peripheral Vascular, Inc.
Tempe, AZ
85281
New measuring equipment for use in incoming quality control (IQC) inspections.
P080025/S064
4/2/14
Sacral Nerve Stimulation, Bowel Implantable Neurostimulator (INS) Interstim Family Medtronic Neuromodulation
Minneapolis, MN 55432
Qualification of two alternative suppliers for a silicone component.
P080025/S065
4/11/14
Sacral Nerve Stimulation, Bowel Implantable Neurostimulator (INS)
Interstim Family
Medtronic Neuromodulation
Minneapolis,  MN 55432
Additional in-process inspections and tooling changes in the manufacturing process of a component of the InterStim II Neurostimulator, at the Medtronic Energy and Component Center.
P080025/S066
4/10/14
SNS Bowel Neurostimulator Implantable InterStim Family Medtronic, Inc.
Minneapolis, MN 55432
Changes to the copper etching process on the printed wiring board substrates.
P080025/S067
4/24/14
SNS Bowel Implantable Neurostimulators (InterStim); SNS Bowel Accessories; SNS Bowel Extensions; SNS Bowel Leads; SNS Bowel Programming Systems; and SNS Bowel Screening Trialing Systems Medtronic, Inc.
Minneapolis, MN 55432
Update the software used at several Medtronic’s manufacturing facilities.
P090003/S031
4/24/14
Express® LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Implement changes that will optimize the resin drying process for the catheter manufacture.
P090006/S014
4/3/14
Complete SE Vascular Stent System Medtronic Vascular
Santa Rosa, CA 95403
Implementation of new coating equipment and process controls.
P090013/S135
4/4/14
Revo MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Manufacturing process change for the printed wiring board (PWB) substrates at a Medtronic second tier supplier. These PWB substrates are used in the manufacture of hybrid substrates at Medtronic’s internal supplier, Medtronic Tempe Campus (MTC), for the devices.
P090013/S137
4/15/14
REVO MRI IPG Medtronic, Inc.
Mounds View, MN 55112
New equipment in the final packaging lines at the Medtronic Puerto Rico Operations Company.
P090018/S025
4/8/14
Esteem System Envoy Medical Corporation
Saint Paul, MN 55110
Acceptance of a manufacturing process change for the Esteem System.
P090022/S021
4/19/14
Softec Intraocular Lenses Lenstec, Inc.
St. Petersburg, FL 33716
Addition of a steam sterilizer.
P100010/S035
4/3/14
Arctic Front and Arctic Front Advance catheters Medtronic Cryocath LP
Mounds View, MN 55112
Updates to the manufacturing steps and fixtures at manufacturing station P09 "Y Block to Shaft Assembly" used in the manufacture of the Arctic Front and Arctic Front Advance catheters.
P100013/S010
4/23/14
Exoseal Vascular Closure Device Cordis Corporation
Fremont, CA
94555
Bring manufacturing of an injection molded component in-house and replace the single- with the multi-cavity molding process.
P100023/S091
4/11/14
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove MN 55311
Change to the delivery cathter assembly manufacturing process.
P100023/S092
4/17/14
ION Paclitaxel-Eluting  Platinum_Chromium Coronary Stent System- Monorail, ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove MN 55311
Change to the manual steps of the stent crimping manufacturing process.
P100023/S093
4/23/14
PROMUS Element Plus Everolimus-Eluting System, ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P100023/S096
4/24/14
ION™ Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Implement changes that will optimize the resin drying process for the catheter manufacture.
P100026/S014
4/4/14
NeuroPace RNS System NeuroPace, Inc.
Mountain View, CA 94043
Add an alternate supplier for a battery component.
P100026/S015
4/14/14
NeuroPace RNS System NeuroPace, Inc.
Mountain View, CA 94043
Modify automated testing equipment.
P100041/S051
4/17/14
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories Edwards Lifesciences LLC
Irvine, CA
92614
Addition of an alternate Self-Contained Biological Indicator in Pouch (SCBIP) used to monitor effectiveness of ethylene oxide sterilization.
P100047/S041
4/4/14
HeartWare® Ventricular Assist System HeartWare, Inc.
Miami Lakes, FL 33014
Modifications to the coating process for the device.
P100049/S008
4/9/14
LINX Reflux Management System Torax Medical, Inc.
Shoreview, MN 55126
Change to the diameter for the weld balls that are at the end of the links that connect the individual LINX device beads.
P110010/S078
4/23/14
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Change to add a new ethylene oxide sterilization chamber.
P110010/S081
4/24/14
PROMUS Element Plus Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Implement changes that will optimize the resin drying process for the catheter manufacture.
P110011/S007
4/17/14
Assurant Cobalt Iliac Balloon-Expandable Stent System Medtronic, Inc.
Santa Rosa, CA 95403
Changes and upgrades to the current electropolishing station.
P110013/S037
4/9/14
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic, Inc.
Santa Rosa, CA 95403
Extension to the retest period for Zotarolimus from 12 months to 24 months.
P110013/S038
4/17/14
Resolute Integrity Zotarolimus-Eluting Coronary Stent System Medtronic, Inc.
Santa Rosa, CA 95403
Changes and upgrades to the current electropolishing station.
P110019/S065
4/15/14
XIENCE V® Everolimus Eluting Coronary Stent System; XIENCE nano® Coronary Stent System Abbott Vascular
Temecula, CA 92589
Change to increase the speed at which the cobalt chromium-based stents are laser cut.
P110021/S038
4/17/14
Edwards SAPIEN™ Transcatheter Heart Valve and Accessories Edwards Lifesciences LLC
Irvine, CA
92614
Addition of an alternate Self-Contained Biological Indicator in Pouch (SCBIP) used to monitor effectiveness of ethylene oxide sterilization.
P110029/S017
4/15/14
ARCHITECT HBsAg Qualitative and HBsAg Qualitative Confirmatory Abbott Laboratories,
Abbott Park, IL 60064
Addition of a newly constructed ISO Class 8 Dispensary Area for buffer preparation.
P110033/S005
4/14/14
Juvéderm Voluma XC Allergan
Goleta, CA
93117
Changes to the ISO classification of the syringe drying, 100% visual inspection, syringe assembly and thermoformed tray packaging rooms.
P110033/S006
4/28/14
Juvéderm Voluma XC Allergan
Goleta, CA
93117
Removal of two in-process control tests used during the manufacture of Juvéderm Voluma XC.
P110037/S014
4/7/14
COBAS® AmpliPrep/
COBAS® TaqMan® CMV Test
Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Addition of a new supplier for a system component used in the manufacture of the COBAS AmpliPrep Instrument.
P110037/S015
4/28/14
COBAS® AmpliPrep/COBAS® TaqMan® CMV Test Roche Molecular Systems, Inc.
Pleasanton, CA 94588
Addition of a new supplier for subassemblies in the manufacture of the COBAS® AmpliPrep Instrument.
P110038/S004
4/16/14
Relay Thoracic Stent-Graft with Plus Delivery System Bolton Medical, Inc.
Sunrise, FL
33325
Increase in sterilization cycle capacity.
P110040/S005
4/3/14
Complete SE Vascular Stent System Medtronic Vascular
Santa Rosa, CA 95403
Implementation of new coating equipment and process controls.
P110042/S028
4/15/14
S-ICD® System Cameron Health, Inc.
San Clemente, CA 92673
Removal of redundant inspections in the manufacturing process.
P110042/S031
4/29/14
Subcutaneous Implantable Defibrillator (S-ICD) System Cameron Health, Inc.
San Clemente, CA 92673
Remove the electrical isolation process monitor from the manufacturing process.
P110042/S032
4/28/14
SQ-RX® Pulse Generator Cameron Health, Inc.
San Clemente, CA 92673
Boston Scientific Corporation (BSC) to be the second supplier for the manufacture process of the high voltage capacitor lids to be used in the device.
P120002/S001
4/16/14
SMART and SMART Control Vascular Stent Systems Cordis Corp.
Fremont, CA
94555
Add an additional semi-automated inspection step to the current pouch sealing inspection.
P120008/S006
4/15/14
ARCHITECT AFP Assay, ARCHITECT AFP Calibrators and ARCHITECT AFP Controls Abbott Laboratories,
Abbott Park, IL 60064
Addition of a newly constructed ISO Class 8 Dispensary Area for buffer preparation.
P120010/S014
4/3/14
MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325
Change to the dye leak testing procedure, dye formulation, and qualification of a new medical tray sealer.
P120010/S017
4/7/14
MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325
New laser system added to the sensor fabrication process for the Enlite Sensor (MMT-7008).
P120016/S001
4/30/14
VASCADE Vascular Closure System (VCS) Cardiva Medical, Inc.
Sunnyvale, CA 94085
Eliminate post-sterilization inspection steps and add subassembly Quality Control Inspection steps to subassemblies.
P130016/S001
4/25/14
Nucleus 24 Hybrid Cochlear System Cochlear Americas
Centennial, CO 80111
Acceptance of a supplier manufacturing process change.

Summary of PMA Originals & Supplements Approved
Originals:  1            
Supplements:  93   

Summary of PMA Originals Under Review
Total Under Review:  52    
Total Active:  27   
Total On Hold:  25       

Summary of PMA Supplements Under Review
Total Under Review:  580     
Total Active:  455
Total On Hold:  125     

Summary of All PMA Submissions Received
Originals:  3      
Supplements:  104

Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals:  93  
Number of Denials:  0
Average Days Fr Receipt to Decision (Total Time):  182.7     
FDA Time:  134.8 Days  MFR Time:  48.0 Days

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