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Medical Devices

September 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

None.

PMA Supplemental Approvals

APPLICATION NUMBER / DATE of APPROVAL DEVICE TRADE NAME COMPANY NAME CITY, STATE, & ZIP DEVICE DESCRIPTION / INDICATIONS
N12159/S033
9/24/14
Real-Time
Surgicel Family of Absorbable Hemostats Ethicon, Inc.
Somerville, NJ 08876
Approval to include X-ray irradiation as an alternative sterilization
process.
P820003/S129
9/5/14
Real-Time
Pasys, Pasys ST, Spectrax S, Spectrax SX, Spectrax SX-HT, Spectrax
SXT, Symbios, Synergyst
Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P850051/S081
9/5/14
Real-Time
Activitrax, Activitrax II, Legend, Legend II, Micro Minix, Minix,
Minix ST, Premier, Prevail, Vitatron Legacy SR
Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P880006/S089
9/12/14
180-Day
SENSOLOG, DIALOG, REGENCY PACEMAKERS St. Jude Medical
Sunnyvale, CA 94085
Approval for the Merlin Patient Care System Programmer Software Model 3330 Version 19.1.
P880086/S245
9/12/14
180-Day
AFFINITY, INTEGRITY, VICTORY, ZEPHYR, ACCENT
PACEMAKERS
St. Jude Medical
Sunnyvale, CA 94085
Approval for the Merlin Patient Care System Programmer Software Model 3330 Version 19.1.
P890003/S311
9/5/14
Real-Time
Elite, Elite II, Minuet, Preva, Preva D, Prodigy, Synergyst II, Thera,
Thera-i, Vitatron Legacy, Vitatron Legacy II, Reveal Insertable Loop
Model 2090 CareLink Programmer
Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P890003/S318
9/30/14
Real-Time
Vitatron Brilliant S+ VDD, Vitatron Brilliant S+ VDD Lead Medtronic, Inc.
Mounds View, MN 55112
Approval for use of new silicone insulation tubing materials.
P900061/S129
9/5/14
Real-Time
Gem, Jewel, Micro Jewel, Jewel Plus, Micro Jewel II, PCD Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P910023/S342
9/12/14
180-Day
ELLIPSE, FORTIFY ASSURA IMPLANTABLE CARDIOVERTER
DEFIBRILLATORS
St. Jude Medical
Sunnyvale, CA 94085
Approval for the Merlin Patient Care System Programmer Software Model 3330 Version 19.1.
P920015/S133
9/5/14
Real-Time
PCD Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P930022/S016
9/5/14
Real-Time
Legend Plus Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P930029/S044
9/10/14
Real-Time
RF Enhancr II, RF Marinr 7Fr, RF Marinr 5Fr, RF Marinr Unipolar, RF Contactr, RF Conductr AF Solutions
Mounds View, MN 55112
Approval for changes to solder and wire required to meet the European Directive 2011/65/EU – Restriction of the Use of Certain Hazardous Substances in Electrical and Electronic Equipment.
P950037/S138
9/16/14
180-Day
Dextrus, Selox, Setrox, Tilda, and Solox Pacing Leads Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the following changes:
1) A minor modification (addition of inner coating) of to the Linoxsmart / VOLTA / Protego ICD leads;
2) Modifications to the current suture sleeve to create a White Suture Sleeve;
3) PA 11 Adapter; and
4) Lead Technical Manual/Labeling updates.
P950039/S030
9/26/14
Special
ThinPrep® Processors 2000/3000 Hologic, Inc.
Marlborough, MA 01752
Approval for clarifications to manufacturing instructions and addition of safety warnings to labeling.
P960016/S048
9/5/14
Special
Livewire TC and Safire EP Ablation Catheters St. Jude Medical
St. Paul, MN
55117
Approval for addition of a new inspection step to the package sealing and sterile package assembly manufacturing procedures and additional clarifications to final package inspection for specific visual inspection procedure, including an inspection step for detecting wrinkles.
P960058/S106
9/10/14
180-Day
HiResolution Bionic Ear System Advanced Bionics
Sylmar, CA
91342
Approval for the Naida CI AquaCase for use with the Naida CI Q70 Sound Processor. The Naida CI AquaCase is an accessory to the HiResolution Bionic Ear System.
P970012/S095
9/5/14
Real-Time
Kappa 400 Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P970013/S060
9/12/13
180-Day
MICRONY PACEMAKERS St. Jude Medical
Sunnyvale, CA 94085
Approval for the Merlin Patient Care System Programmer Software Model 3330 Version 19.1.
P970051/S121
9/9/14
Real-Time
Nucleus® 24 Cochlear™ Implant System: Addition of Wireless Accessories Cochlear Americas
Centennial, CO 80111
Approval for changes to the firmware of the CP900 Series (Nucleus 6) Sound Processor and CR200 Series Remote Assistants which will allow the use of wireless
accessories.
P980016/S489
9/5/14
Real-Time
EnTrust, Gem, Gem II, Gem III, Intrinsic, Marquis, Maximo, Maximo
II, Onyx, Protecta DF4, Protecta, Protecta XT DF4, Protecta XT,
Secura DF4, Secura, Virtuoso, Virtuoso II, Evera S DR, Evera S VR,
Evera XT DR, Evera XT VR
Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P980022/S143
9/25/14
135-Day
Paradigm REAL-Time System,
Paradigm REAL-Time Revel System,
Guardian REAL-Time System,
MiniLink REAL-Time System,
iPro2 Professional CGM System
Medtronic MiniMed
Northridge, CA 91325
Approval for a change to the supplier and material of the battery anode for the MiniLink REAl-Time Transmitter (Model: MMT-7703), the iPro2 Recorder (Model: MMT-7741) and the MiniLink REAL-Time Transmitter (Model: MMT-7703), which are components of the Paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, MiniLink REAL-Time, iPro2 Professional CGM and MiniMed 530G Systems.
P980023/S060
9/16/14
180-Day
VOLTA, Protego, Kainox, Linoxsmart ICD Leads Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the following changes:
1) A minor modification (addition of inner coating) of to the Linoxsmart / VOLTA / Protego ICD leads;
2) Modifications to the current suture sleeve to create a White Suture Sleeve; 3) PA 11 Adapter; and
4) Lead Technical Manual/Labeling updates.
P980035/S382
9/5/14
Real-Time
Adapta, Advisa, AT500, EnPulse, EnRhythm, Kappa 600, Kappa 650,
Kappa 700, Kappa 800, Kappa 900, Relia, Sensia, Sigma, Versa
Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P980037/S042
9/2/14
Real-Time
AngioJet® Ultra Thrombectomy System Bayer Medical Care Inc.
Minneapolis, MN 55433
Approval for a change to the design and manufacturing process of the mid-joint connection on the AngioJet Ultra Thrombectomy Sets.
P980050/S092
9/5/14
Real-Time
Jewel AF, GEM III AT Implantable Cardioverter Defibrillator Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P990001/S118
9/5/14
Real-Time
Diva family (includes Diamond II, Ruby II, Topaz II, Jade II, Vita
DDDR, Vita DDD and Vita VVIR), Dema Family (includes Clarity
DDDR, Clarity SSIR, Diamond III, Ruby III, Topaz III, Jade III, Vita
II DDDR and Vita II), Selection AFm, C-Series Devices, T-Series Devices
Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P000008/S031
9/24/14
180-Day
LAP-BAND® Adjustable Gastric Banding System Allergan, Inc.
Austin, TX
78746
Approval of the post-approval study protocol.
P010015/S242
9/5/14
Real-Time
Consulta CRT-P, InSync, InSync III, Syncra CRT-P Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P010031/S451
9/5/14
Real-Time
Concerto, Concerto II CRT-D, Consulta CRT-D, InSync ICD, InSync
II Marquis, InSync II Protect, InSync III Marquis, InSync Marquis,
InSync Maximo, InSync Sentry, Maximo II CRT-D, Maximo II DF4,
Protecta CRT-D, Protecta DF4, Protecta XT CRT-D, Protecta XT
DF4, Brava CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P010032/S081
9/16/14
Real-Time
St. Jude Spinal Cord Stimulation System St. Jude Medical
Plano, TX
75024
Approval for a material change to the port plug used in the approved implanted pulse generators (IPG Models 3608, 3688, 3716, 3788 and 3789). The port plug is an accessory to the IPG used to block tissue ingress into the IPG header. When implanting only a single lead in an IPG containing dual lead ports, the port plug is inserted into the unused lead port and secured by tightening the setscrew onto the port plug.
P020002/S008
9/18/14
Real-Time
ThinPrep® Imaging System Hologic, Inc.
Marlborough, MA 01752
Approval for modifications of the ThinPrep Imager Duo Imaging Station software.
P020049/S003
9/29/14
180-Day
ProCol Vascular Bioprosthesis Hancock Jaffe
Irvine, CA
92618
Approval for a manufacturing site located in Irvine, California.
P030011/S027
9/12/14
Real-Time
SynCardia Companion 2 Driver System SynCardia Systems, Inc.
Tucson, AZ
85713
Approval for several design changes to the SynCardia Companion 2
Driver pressure sensor printed circuit board assembly (PCBA) and the addition of an alternate supplier for the pressure sensor PCBA.
P030022/S027
9/5/14
135-Day
REFLECTION Ceramic Acetabular Hip System (RCHS) Smith & Nephew, Inc.
Memphis, TN 38116
Approval for the addition of a vapor degreaser and machining equipment.
P030035/S123
9/12/14
180-Day
FRONTIER, FRONTIER II, ANTHEM CRT-PACEMAKERS St. Jude Medical
Sunnyvale, CA 94085
Approval for the Merlin Patient Care System Programmer Software Model 3330 Version 19.1.
P030054/S273
9/12/14
180-Day
QUADRA ASSURA, UNIFY ASSURA CRT-DEFIBRILLATORS St. Jude Medical
Sunnyvale, CA 94085
Approval for the Merlin Patient Care System Programmer Software Model 3330 Version 19.1.
P040037/S060
9/19/14
Panel-Track
GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface W.L. Gore and Associates, Inc.
Flagstaff, AZ
86005
Approval for the GORE VIABAHN Endoprosthesis and GORE VIABAHN Endoprosthesis with Heparin Bioactive Surface. These devices are indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery de novo and restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 7.5 mm.  These devices are also indicated for improving blood flow in patients with symptomatic peripheral arterial disease in  superficial femoral artery in-stent restenotic lesions up to 270 mm in length with reference vessel diameters ranging from 4.0 – 6.5 mm.
P040046/S005
9/19/14
180-Day
Natrelle® Silicone-Filled Breast Implants Allergan
Goleta, CA
93117
Approval for labeling documents for the NATRELLE® 410 Highly Cohesive
Anatomically Shaped Silicone-Filled Breast Implants containing 10-year data from the final post-approval study report.
P050034/S014
9/12/14
Real-Time
Implantable Miniature Telescope™ (IMT) VisionCare Ophthalmic Technologies
Saratoga, CA
95070
Approval for a change to the position of the eyelet on each haptic of the carrier for the Implantable Miniature Telescope (by Dr. Isaac Lipshitz) (IMT) Models Wide Angle 2.2X and Wide Angle 2.7X.
P050038/S022
9/24/14
180-Day
ARISTA AH Absorbable Hemostat Medafor, Inc.
Minneapolis, MN  55429
Approval for a manufacturing site located at Davol, Inc., in Woburn, Massachusetts.
P050047/S037
9/11/14
135-Day
Juvéderm Hyaluronate Gel Implants  Juvéderm Voluma XC Allergan
Goleta, CA
93117
Approval for moving bioburden testing, conducted as part of routine quality control procedures for Juvéderm Hyaluronate Gel Implants and Juvéderm Voluma XC, from a contract laboratory to in-house.
P060008/S105
9/29/14
180-Day
TAXUS Liberte Paclitaxel-Eluting Coronary Stent System (Monorail and Over-the-Wire) Boston Scientific Corporation
Maple Grove, MN 55311
Approval of the post-approval study protocol.
P060028/S001
9/9/14
180-Day
Mentor® MemoryShape™ Silicone Gel-filled Breast Implants Mentor Worldwide LLC
Santa Barbara, CA  93111
Approval for four additional MemoryShape™ Breast Implant Styles (MM+, MH,
TM+ and LM+).
P060039/S059
9/4/14
180-Day
Attain StarFix Lead Medtronic, Inc.
Mounds View, MN 55112
Approval for updates to the finished product release criteria for Content Uniformity and Elution for the Attain StarFix Model 4195 Lead.
P060039/S062
9/12/14
180-Day
Attain StarFix Lead Medtronic, Inc.
Mounds View, MN 55112
Approval of the request to close the Chronic Extraction post-approval study for the device.
P070008/S054
9/16/14
180-Day
Celerity, Corox LV Pacing Leads Biotronik, Inc.
Lake Oswego, OR 97035
Approval for the following changes:
1) A minor modification (addition of inner coating) of to the Linoxsmart / VOLTA / Protego ICD leads;
2) Modifications to the current suture sleeve to create a White Suture Sleeve;
3) PA 11 Adapter; and
4) Lead Technical Manual/Labeling updates.
P070015/S107
9/23/14
180-Day
XIENCE V® Everolimus-Eluting Stent System (RX and OTW) and XIENCE nano® Everolimus-Eluting Coronary Stent System (RX) Abbott Vascular, Inc.
Santa Clara, CA 95054
Approval for a change to the particulate test method and particulate specification used for the stability testing of the XIENCE V and XIENCE nano Everolimus-Eluting Coronary Stent Systems.
P070015/S117
9/4/14
180-Day
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent Systems Abbott Vascular, Inc.
Santa Clara, CA 95054
Approval for the post approval study labeling updates for the clinical studies
followed under this PMA for the XIENCE V and XIENCE nano Everolimus Eluting Coronary
Stents.
P080027/S017
9/2/14
Real-Time
OraQuick® HCV Rapid Antibody Test OraSure Technologies, Inc.
Bethlehem, PA 18015
Approval for changes to the expiration dating for the OraQuick® HCV Visual Reference Panel to a five month expiration date for pouched and un-pouched devices that are protected from light and 15 days for devices that are not protected from light.
P090003/S029
9/4/14
Real-Time
Express LD Iliac Premounted Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a change to the resin material used in the catheter tip.
P090013/S147
9/5/14
Real-Time
Revo MRI, EnRhythm MRI Medtronic, Inc.
Mounds View, MN 55112
Approval for enhancements to Model 9986 Desktop/BOSS for use on the Model 2090 Medtronic CareLink Programmer for the devices.
P090018/S027
9/10/14
Real-Time
Esteem® Envoy Medical Corporation
St. Paul, MN
55110
Approval for changes to capacitance specifications for the Esteem sensor and driver components, and the Esteem system is intended to alleviate hearing loss in
patients by replicating the ossicular chain and providing additional gain. The Esteem is indicated for patients with hearing loss that meet the following criteria:
1) 18 years of age or older; 2) Stable bilateral sensorineural hearing loss;
3) Moderate to severe sensorineural hearing loss defined by Pure Tone Average (PTA);
4) Unaided speech discrimination test score greater than or equal to 40%;
5) Normally functioning Eustachian tube
6) Normal middle ear anatomy;
7) Normal tympanic membrane;
8) Adequate space for Esteem implant determined via a high resolution CT scan; and
9) Minimum 30 days of experience with appropriately fit hearing aids.
P100021/S032
9/3/14
180-Day
Endurant II Stent Graft System Medtronic Vascular
Santa Rosa, CA 95403
Approval for a manufacturing site located at Medtronic Mexico EG., in Sonora, Mexico.
P100026/S020
9/2/14
180-Day
Neuropace RNS System Neuropace, Inc.
Mountain View, CA 94043
Approval of the post-approval study protocol.
P100026/S021
9/3/14
180-Day
Neuropace RNS System Neuropace, Inc.
Mountain View, CA 94043
Approval of the post-approval study protocol.
P100026/S022
9/5/14
180-Day
Neuropace RNS System Neuropace, Inc.
Mountain View, CA 94043
Approval of the post-approval study protocol.
P100034/S010
9/28/14
180-Day
Optune™ NovoCure, Ltd.
Rye Beach, NH
03871
Approval for a trade name change from the NovoTTF-100A System to Optune™.  You have also requested that the components of the NovoTTF-100A System (a plugin power supply; charger for portable batteries; device & battery carrying bag; portable battery; and, connection cable & box), along with the transducer array and electric field generator (the device), be named the Optune™ Treatment Kit.
P100047/S047
9/12/14
Real-Time
HeartWare® Ventricular Assist System HeartWare Inc.
Miami Lakes, FL 33014
Approval for adding a torque specification to the HVAD Pump Design Specification Document.
P110004/S005
9/11/14
135-Day
NIRxcell™ CoCr Coronary Stent on RX Medinol Ltd.
Tel-Aviv, Israel 6158101
Approval to introduce a semi-automated hydrophilic coating
process while retaining the manual process as an alternate option.
P110010/S090
9/17/14
Real-Time
PROMUS Element Plus Monorail Everolimus-Eluting Platinum Chromium Stent System;
Promus PREMIER Monorail Everolimus-Eluting Platinum Chromium Stent System
Boston Scientific Corporation
Maple Grove, MN 55311
Approval for changes to the accessory kit (removal of CLIPIT™ hypotube clips, substitution of flushing needle manufactured by new vendor, modification of carrier tube clip and update to the eDFU) and is indicated for improving luminal diameter in patients with symptomatic heart disease or documented silent ischemia due to de novo lesions in native coronary arteries >2.25 mm to <4.00 mm in diameter in lesions <34 mm in length.
P110014/S003
9/24/14
180-Day
MarginProbe System Dune Medical Devices Incorporated
Framingham, MA
01701
Approval for the modification made to the MarginProbe console from
MarginProbe type 1.1 to MarginProbe type 1.2.
P110019/S062
9/4/14
180-Day
XIENCE PRIME and XIENCE Xpedition Everolimus Eluting Coronary Stent Systems Abbott Vascular, Inc.
Santa Clara, CA 95054
Approval for the post approval study labeling updates for the clinical studies
followed under this PMA for the XIENCE PRIME and XIENCE Xpedition Everolimus Eluting
Coronary Stents.
P110019/S069
9/26/14
135-Day
XIENCE Xpedition Everolimus Eluting Coronary Stent Systems Abbott Vascular
Temecula, CA 92591
Approval for a change to the stent process monitoring and sampling plan.
P110019/S070
9/3/14
Real-Time
XIENCE Alpine™ Everolimus Eluting Coronary Stent System Abbott Vascular
Temecula, CA 92591
Approval to change the distal balloon shaft, distal outer member and proximal hypotube components for the Xience Xpedition Everolimus Eluting Coronary Stent System. You indicated that upon implementation of these changes, the new name for the coronary stent system will be the XIENCE Alpine™ Everolimus Eluting Coronary Stent System.
P110023/S010
9/3/14
180-Day
EverFlex Self-Expanding Peripheral Stent System (Everflex) Ev3, Inc.
Plymouth, MN 55441
Approval of the post-approval study protocol.
P110033/S007
9/11/14
135-Day
Juvéderm Voluma XC Allergan
Goleta, CA
93117
Approval for moving bioburden testing, conducted as part of routine quality control procedures for Juvéderm Hyaluronate Gel Implants and Juvéderm Voluma XC, from a contract laboratory to in-house.
P110035/S026
9/17/14
135-Day
Epic™ Vascular Self-Expanding Stent System Boston Scientific Corporation
Maple Grove, MN 55311
Approval for a modification to the electropolishing finishing operation for the Epic™ Vascular Self-Expanding Stent System.
P120006/S010
9/30/14
180-Day
Ovation and Ovation Prime Abdominal Stent Graft System TriVascular, Inc.
Santa Rosa, CA 95403
Approval for changes to the CustomSeal Kit to achieve a shorter cure time of the fill polymer.
P120006/S014
9/9/14
Real-Time
Ovation Prime Abdominal Stent Graft System Trivascular, Inc.
Santa Rosa, CA 95403
Approval for modifications to the Fill Polymer Kit.
P120010/S003
9/25/14
135-Day
MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325
Approval for a change to the supplier and material of the battery anode for the MiniLink REAl-Time Transmitter (Model: MMT-7703), the iPro2 Recorder (Model: MMT-7741) and the MiniLink REAL-Time Transmitter (Model: MMT-7703), which are components of the Paradigm REAL-Time, Paradigm REAL-Time Revel, Guardian REAL-Time, MiniLink REAL-Time, iPro2 Professional CGM and MiniMed 530G Systems.
P120010/S032
9/29/14
180-Day
MiniMed 530G System Medtronic MiniMed
Northridge, CA 91325
Approval of the post-approval study protocol.
P130008/S003
9/19/14
180-Day
Inspire II Upper Airway Stimulator Inspire Medical Systems
Maple Grove, MN 55369
Approval of the post-approval study protocol.
P130009/S002
9/12/14
180-Day
Edwards SAPIEN XT™ Transcatheter Heart Valve and Accessories Edwards Lifesciences, LLC
Irvine, CA
92614
Approval of the post-approval study protocol.
P130016/S003
9/12/14
180-Day
Nucleus Hybrid L24 Implant System Cochlear Americas
Centennial, CO 80111
Approval of the post-approval study protocol.
P130016/S004
9/11/14
180-Day
Nucleus Hybrid L24 Implant System Cochlear Americas
Centennial, CO 80111
Approval of the post-approval study protocol.
P130016/S007
9/9/14
Real-Time
Nucleus® 24 Hybrid System: Wireless Accessories Cochlear Americas
Centennial, CO 80111
Approval for changes to the firmware of the CP900 Series (Nucleus 6) Sound Processor and CR200 Series Remote Assistants which will allow the use of wireless
accessories.
P130021/S004
9/2/14
180-Day
Medtronic CoreValve™ System (MCS): Transcatheter Aortic Valve (TAV),
CoreValve™ Evolut™),
Delivery Catheter
System (DCS), and Compression
Loading System
Medtronic CoreValve, LLC Approval for a new Compression Loading System (G4 CLS), a manufacturing site located at Synergy Health Westport Limited, Synergy Health Place, Lodge Road, Westport,Co., Mayo, Ireland, and the gamma sterilization of the finished G4 CLS.

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/S051
9/19/14
EBI OsteoGen Implantable Bone Growth Stimulators EBI, LLC d/b/a Biomet Spine & Bone Healing Technologies
Parsippany, NJ 07054
Additional of an alternate component supplier.
P820003/S131
9/24/14
Disposable EPG Cover, EPG
Disposable Pouch
Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P830061/S114
9/3/14
CapSure Sense Lead Medtronic Inc.
Mounds View, MN 55112
Addition of a visual verification system to ensure that the correct inner tray is being used for packaging leads and accessories.
P830061/S115
9/24/14
Adhesive, CapSure Sense Lead, CapSure SP Novus Lead, Vitatron Crystalline Lead
Vitatron Excellence PS+ Lead
Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P840001/S281
9/15/14
SCS Implantable Neurostimulators Restore Family Medtronic, Inc.
Minneapolis, MN 55432
Changes to the thermal shock cycling process.
P850035/S038
9/19/14
SpF XL IIb Implantable Spinal Fusion Stimulators EBI, LLC d/b/a Biomet Spine & Bone Healing Technologies
Parsippany, NJ 07054
Additional of an alternate component supplier.
P850079/S067
9/9/14
Frequency (Methafilicon A and B) Soft (Hydrophilic) Extended-wear
Contact Lenses
CooperVision, Inc.
Pleasanton, CA 94588
Replacement of the Fedegari Therma 3 FOAF3 autoclave (Fedegari W) with
Therma 4 FOAF3/A Fedegari autoclave (Fedegari F).
P850089/S111
9/24/14
CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P860004/S211
9/12/14
Medtronic SynchroMed II Pump Medtronic, Inc.
Minneapolis, MN 55432
Replacement of the current Final Function test (FFT) software version with a new software revision.
P880086/S246
9/4/14
Accent, Entity, Identity, Sustain XL, Verity, Victory and Zephyr family of Pacemaker Devices St. Jude Medical
Implantable Electronic Systems
Sylmar, CA
91342
Alternate supplier for the hybrid assembly die coat material for the devices.
P890003/S321
9/24/14
Battery Check Monitor, CapSure VDD 2, CareLink Programmer,
CareLink Programmer RF Head, Desktop BOSS Software,
ECG Cable Lead Analyzer, Medtronic CareLink Monitor,
Package Adaptor Cable, Service Kit-Pacemaker Repair Kit, Stylus and Calibration SW
Vitatron Brilliant S+ VDD Lead, Vitatron Brilliant S+VDD Lead, Wireless Network Adapter Card, Xircom Combination Ethernet/Modem Card
Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P900061/S131
9/24/14
ACE Header,
Cable, Defibrillation Support Device (DISD), End CapEpicardial Patch Lead, Patient Magnet, Upsizing Sleeve
Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P910056/S018
9/10/14
enVista® Hydrophobic Acrylic Intraocular Lens Bausch & Lomb, Inc.
Irvine, CA
92618
Acceptance of an alternate cytotoxicity testing lab.
P910077/S146
9/5/14
LATITUDE Wave Communication Boston Scientific Corporation
St. Paul, MN
55112
Use of an existing Surface Mount Technology manufacturing line as an alternate to produce printed circuit assemblies.
P920015/S140
9/24/14
SPRINT QUATTRO LEAD, SUBCUTANEOUS LEAD, TRANSVENE CS/SVC LEAD Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P930029/S046
9/24/14
RF CONTACTR, RF ENHANCR II, RF MARINR, RF MARINR UNIPOLAR, RF CONDUCTR CATHETERS Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P930039/S116
9/3/14
CapSureFix Novus Lead Medtronic Inc.
Mounds View, MN 55112
Addition of a visual verification system to ensure that the correct inner tray is being used for packaging leads and accessories.
P930039/S117
9/24/14
CapSure Fix Novus Lead Medtronic, Inc.
Mounds View, MN 55112
Increase in the staging duration for the sleeveheads, couplers, and retainers and for the usage of an unheated heptane bath instead of a heated heptane bath.
P930039/S118
9/24/14
CAPSUREFIX LEAD,CAPSUREFIX NOVUS LEAD,SUREFIX LEAD,VITATRON CRYSTALLINE ACTIVE FIXATION LEAD, TORQUE CLIP DEVICE-ACCESSORIES Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P950005/S052
9/12/14
Celsius FLTR Bi-directional catheter Biosense Webster, Inc.
Diamond Bar, CA 91765
Modification of a process used to manufacture the catheters' quad lumen soft tip.
P950020/S069
9/11/14
Flextome Cutting Balloon Microsurgical Dilation Device Boston Scientific Corporation
Maple Grove, MN 55331
Implement an inspection protocol of the balloon protector component of the Flextome Cutting Balloon Microsurgical Dilatation device.
P950024/S062
9/3/14
CapSure Epicardial Pacing Lead Medtronic Inc.
Mounds View, MN 55112
Outsource the manufacture of the electrode insulator used in the CapSure Epicardial Pacing Lead.
P950024/S063
9/24/14
CapSure Epicardial Pacing Lead Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P950039/S029
9/12/14
ThinPrep Processor 2000/ 3000 Hologic, Inc.
Marlborough, MA 01752
The following ten changes: Quality Control (QC) instructions for Microscope Slides Ink and Chip, add a new Friction Feeder Equipment, TP-00372 Documentation update, Electrical Safety Testing, Transfer of legacy (Legacy PMR) documentation into Agile document control system, Instruction clarification regarding air vent holes during machine assembly, Mechanical Driver Boards testing, PreservCyt QC Testing, Change in ownership of LCD board manufacturer, and improvement to fixtures used in the screen printing process (Squeegee).
P960009/S204
9/15/14
DBS Implantable Neurostimulators Activa Family Medtronic, Inc.
Minneapolis, MN 55432
Changes to the thermal shock cycling process.
P960040/S329
9/4/14
Origen ICDs, Inogen ICDs,
Dynagen ICDs
Boston Scientific Corporation
St. Paul, MN
55112
Change in a quality control inspection test limit for the high voltage capacitor.
P960040/S330
9/10/14
ORIGEN®, INOGEN®, DYNAGEN® Implantable Cardioverter Defibrillators (ICDs) Boston Scientific Corporation
St. Paul, MN
55112
Implement the ASYS Laser Mark System.
P960040/S331
9/18/14
INCEPTA™ICD,
ENERGEN™ICD,
PUNCTUA™ICD,
DYNAGEN™ICD
Boston Scientific Corporation
St. Paul, MN
55112
Vertically integrate the manufacture of the feedthru ferrules for the batteries used in the devices.
P980016/S497
9/10/14
Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD Medtronic, Inc.
Mounds View, MN 55112
New Case to Cover Welder Machine at MECC to increase manufacturing capacity for the devices.
P980016/S498
9/12/14
Evera S DR ICD; Evera S VR ICD;
Evera XT DR ICD; Evera XT VR ICD
Medtronic CRDM
Mounds View, MN 55112
Reduce the frequency of capacitor weld monitoring for the devices.
P980016/S499
9/12/14
Evera S DR ICD,
Evera S VR ICD,
Evera XT DR ICD,
Evera XT VR ICD
Medtronic CRDM
Mounds View, MN 55112
Second source supplier for the transformer shield.
P980016/S501
9/24/14
EGMP5 Download Software Application, Evera S DR ICD, Evera S VR ICD, Evera XT DR ICD, Evera XT VR ICD, Maximo II ICD, Patient Magnet, Protecta ICD, Protecta XT ICD, Secura ICD,
Virtuoso II DR/VR ICD
Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P980035/S390
9/10/14
Adapta, Versa, Sensia, and Relia IPG Medtronic, Inc.
Mounds View, MN 55112
Changes to the Proteus test system which is used for electrical testing of fully assembled devices.
P980035/S393
9/24/14
Adapta, Versa, Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P980035/S394
9/25/14
Adapta, Versa, and Sensia IPG, Advisa DR IPG, Advisa DR MRI IPG and Relia IPG Medtronic, Inc.
Mounds View, MN 55112
Updates to the temperature exposure requirements on device assembly drawings.
P980037/S043
9/4/14
AngioJet Rheolytic Thrombectomy System Bayer Medical Care Inc.
Minneapolis, MN 55433
Alternate component vendor for the low pressure pump seal.
P980044/S019
9/26/14
SUPARTZ Seikagaku Corporation
Tokyo, Japan
Replacement of a back-up test system used during manufacturing.
P980050/S096
9/24/14
Transvene CS/SVC Lead Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P000021/S026
9/25/14
Dimension Vista® TPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Addition of an alternate automated column (Interchim puriFlash® purification System) purification procedure to the existing manual column chromatography purification procedure in the Europium particle Raw Material (EPRM) manufacturing process.
P000025/S080
9/12/14
COMBI 40+ Cochlear Implant System (Mi1000 MED-EL CONCERT and SONATATI 100) MED-EL Elektro-Medizinische Geräte GmbH
Innsbruck - Fürstenweg
Austria
77a
Alternate electrode supplier.
P010012/S369
9/10/14
Cardiac Resynchronization Therapy-Defibrillator
(CRT-D)
ORIGEN®, INOGEN®,
DYNAGEN®
Boston Scientific Corporation
St. Paul, MN
55112
Implement the ASYS Laser Mark System.
P010012/S370
9/18/14
INCEPTA™
CRT-D, ENERGEN™
CRT-D, PUNCTUA™
CRT-D, DYNAGEN™ CRT-D, INOGEN™ CRT-D, ORIGEN™ CRT-D
Boston Scientific Corporation
St. Paul, MN
55112
Vertically integrate the manufacture of the feedthru ferrules for the batteries used in the devices.
P010013/S059
9/9/14
NovaSure Impedance Controlled Endometrial Ablation System Hologic, Inc.
Marlborough, MA 01752
Sterilization process change to reduce the aeration time in the sterilization process.
P010015/S249
9/24/14
Attain Bipolar OTW Lead, Attain OTW Lead, Consulta CRT-P, Syncra CRT-P, Viva
CRT-P
Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P010015/S250
9/25/14
Consulta CRT-P, Syncra CRT-P and Viva CRT-P Medtronic, Inc.
Mounds View, MN 55112
Updates to the temperature exposure requirements on device assembly drawings.
P010031/S461
9/10/14
Brava CRT-D, Brava Quad CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D Medtronic, Inc.
Mounds View, MN 55112
New Case to Cover Welder Machine at MECC to increase manufacturing capacity for the devices.
P010031/S462
9/12/14
Brava CRT-D; Brava Quad CRT-D; VivaQuad S CRT-D; Viva Quad XT CRT-D; Viva S CRT-D; Viva XT CRT-D Medtronic CRDM
Mounds View, MN 55112
Reduce the frequency of capacitor weld monitoring for the devices.
P010031/S463
9/12/14
Brava CRT-D,
Brava Quad CRT-D
Viva Quad S CRT-D, Viva Quad XT,
Viva S CRT-D,
Viva XT CRT-D
Medtronic CRDM
Mounds View, MN 55112
Second source supplier for the transformer shield.
P010031/S465
9/24/14
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D,
Consulta CRT-D,
Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D, Viva Quad S CRT-D, Viva Quad XT CRT-D, Viva S CRT-D, Viva XT CRT-D
Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P010068/S041
9/12/14
Celsius FLTR Uni-directional Catheter Biosense Webster, Inc.
Diamond Bar, CA 91765
Modification of a process used to manufacture the catheters' quad lumen soft tip.
P020027/S021
9/25/14
Dimension Vista® FPSA Flex® Reagent Cartridge Siemens Healthcare Diagnostics, Inc.
Newark, DE
19714
Addition of an alternate automated column (Interchim puriFlash® purification System) purification procedure to the existing manual column chromatography purification procedure in the Europium particle Raw Material (EPRM) manufacturing process.
P020045/S061
9/25/14
Freezor Cardiac CryoAblation Catheter, Freezor Xtra Surgical Cardiac CryoAblation Device, Freezor Max Surgical Cardiac CryoAblation Device Medtronic CryoCath LP
Quebec, Canada H9R 5Z8
Additional controlled environment area (CEA) at the Medtronic CryoCath Montreal facility (Pointe-Claire building).
P030011/S029
9/29/14
SynCardia Temporary Total Artificial Heart (TAH-t) System Syncardia Systems, Inc.
Tucson, AZ
85713
Manufacturing transfer of various injection molded parts belonging to the Freedom Driver to a new supplier.
P030031/S060
9/12/14
ThermoCool Catheters For the Treatment of Type I Atrial Flutter and Atrial Fibrillation Biosense Webster, Inc.
Diamond Bar, CA 91765
Modification of a process used to manufacture the catheters' quad lumen soft tip.
P030032/S017
9/5/14
PREVELLE Silk Genzyme Corporation
Genzyme Biosurgery
Ridgefield, NJ 07657
Addition of endotoxin testing to the Purified Water raw material specification.
P030035/S124
9/4/14
Anthem and Frontier family of CRT-P Devices St. Jude Medical
Implantable Electronic Systems
Sylmar, CA
91342
Alternate supplier for the hybrid assembly die coat material for the devices.
P030036/S074
9/24/14
SelectSecure Lead, Anchoring Sleeve Kit Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P040036/S045
9/12/14
ThermoCool Catheters For the Treatment of Ventricular Tachycardia Biosense Webster, Inc.
Diamond Bar, CA 91765
Modification of a process used to manufacture the catheters' quad lumen soft tip.
P040045/S047
9/5/14
VISTAKON (Senofilcon A) Brand Contact Lenses Johnson & Johnson Vision Care, Inc.
Jacksonville, FL 32256
Modification of a test method for leachable components.
P040050/S011
9/16/14
Macroplastique Implants Uroplasty, Inc.
Minnetonka, MN 55343
Addition of an alternative bacterial endotoxin testing facility.
P050027/S007
9/9/14
KARL STORZ Photodynamic D-Light C (PDD) System Karl Storz Endoscopy
El Segundo, CA 90245
Replace the original card-edge connector with a new card-edge connector.
P050037/S054
9/2/14
Radiesse Dermal Filler Merz North America, Inc.
Franksville, WI 53126
Scale-up of the wash process for components used in the manufacture of Radiesse Dermal Filler.
P050052/S059
9/2/14
Radiesse Dermal Filler Merz North America, Inc.
Franksville, WI 53126
Scale-up of the wash process for components used in the manufacture of Radiesse Dermal Filler.
P060039/S063
9/24/14
Attain StarFix Lead Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P080006/S071
9/18/14
ATTAIN ABILITY LEADS Medtronic, Inc.
Mounds View, MN 55112
Update to the component and lead drawings for the ring monolithic
controlled release device (MCRD) component, and the corresponding manufacturing processes, to include additional inspection criteria.
P080006/S072
9/24/14
Attain Ability Lead, Attain Performa Quadripolar Lead Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P080011/S031
9/9/14
Biofinity (comfilcon A) Soft (Hydrophilic) Extended-wear Contact Lenses CooperVision, Inc.
Pleasanton, CA 94588
Replacement of the Fedegari Therma 3 FOAF3 autoclave (Fedegari W) with
Therma 4 FOAF3/A Fedegari autoclave (Fedegari F).
P090007/S012
9/19/14
Elecsys® Anti-HCV Immunoassay, Elecsys® PreciControl Anti-HCV for use on the cobas e 411 Immunoassay Analyzer Roche Diagnostics
Indianapolis, IN 46250
Change in the manufacturing process for a bulk solution formulation.
P090008/S014
9/19/14
Elecsys® Anti-HCV Immunoassay, Elecsys® PreciControl Anti-HCV for use on the
cobas e 601 and cobas e 602 Immunoassay Analyzer
Roche Diagnostics
Indianapolis, IN 46250
Change in the manufacturing process for a bulk solution formulation.
P090009/S012
9/19/14
Elecsys® Anti-HCV Immunoassay, Elecsys® PreciControl Anti-HCV for use on the MODULAR ANALYTICS EI70 Analyzer Roche Diagnostics
Indianapolis, IN 46250
Change in the manufacturing process for a bulk solution formulation.
P090013/S153
9/3/14
CapSureFix MRI Lead Medtronic Inc.
Mounds View, MN 55112
Addition of a visual verification system to ensure that the correct inner tray is being used for packaging leads and accessories.
P090013/S155
9/24/14
CapSure Fix MRI Lead Medtronic, Inc.
Mounds View, MN 55112
Increase in the staging duration for the sleeveheads, couplers, and retainers and for the usage of an unheated heptane bath instead of a heated heptane bath.
P090013/S156
9/24/14
CapSureFix MRI Lead, Revo MRI IPG Medtronic, Inc.
Mounds View, MN 55112
Use of FACTORYworks Release 7.11 manufacturing software.
P090016/S010
9/3/14
Belotero Balance Dermal Filler Merz North America, Inc.
Franksville, WI  53126
Manufacturing changes to the clean room associated with the manufacture of the Belotero Balance Dermal Filler.
P090016/S011
9/9/14
Belotero Balance Dermal Filler Merz North America, Inc.
Franksville, WI  53126
Sampling changes during product manufacture and during final release testing for the Belotero Balance product.
P090016/S012
9/10/14
Belotero Balance Dermal Filler Merz North America, Inc.
Franksville, WI  53126
Implementation of monitoring of rinse water from the cleaning of items used during the manufacture of the Belotero Balance Dermal Filler.
P100010/S043
9/25/14
Arctic Front Cardiac Cryoablation Catheter, Arctic Front Advance Cardiac Cryoablation Catheter, Freezor Max Cardiac CryoAblation Catheters Medtronic CryoCath LP
Quebec, Canada H9R 5Z8
Additional controlled environment area (CEA) at the Medtronic CryoCath Montreal facility (Pointe-Claire building).
P100023/S105
9/12/14
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Maple Grove, MN 55311 Changes to the inspection of inner subassemblies on the Stent Delivery Catheters.
P100023/S106
9/11/14
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System Boston Scientific Maple Grove, MN 55311 Changes to optimize the Over-The-Wire (OTW) catheter inspection process.
P100029/S017
9/30/14
Trifecta™ Valve St. Jude Medical
St. Paul, MN
55117
Alternate laser cutting system for manufacturing Trifecta valve components.
P110010/S092
9/12/14
PROMUS Element Plus Everolimus-Eluting Stent System/ ROMUS Premier Everolimus-Eluting Stent System Boston Scientific Maple Grove, MN 55311 Changes to the inspection of inner subassemblies on the Stent Delivery Catheters.
P110010/S093
9/11/14
PROMUS Element Plus/ Promus, PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System Boston Scientific Maple Grove, MN 55311 Changes to optimize the Over-The-Wire (OTW) catheter inspection process.
P110038/S006
9/30/14                                   
Relay Thoracic Stent-Graft with Plus Delivery System Bolton Medical, Inc.
Sunrise, FL
33325
Alternate colorant in the delivery system tip.
P110043/S007
9/5/14
Omnilink Elite® Vascular Balloon-Expandable Stent System Abbott Vascular
Santa Clara, CA 95054
Addition of an alternate test method for a material component.
P110043/S009
9/30/14
Omnilink Elite® Vascular Balloon-Expandable Stent System Abbott Vascular
Santa Clara, CA 95054
Addition of an alternate supplier site for device components.
P120012/S004
9/25/14
Abbott RealTime HCV Genotype II Abbott Molecular Incorporated
Des Plaines, IL 60018
Manufacturing process changes and in-process quality control method changes to synthesize oligonucleotides on a larger scale.
P120020/S005
9/2/14
Supera Peripheral Stent System Abbott Vascular
Santa Clara, CA 95054
Replacement of ovens used for stent manufacturing.
P130005/S003
9/26/14
Diamondback 360° Coronary Orbital Atherectomy System; consisting of:
Diamondback 360° Coronary Orbital Atherectomy Device, Orbital Atherectomy System Pump, Viperwire Advance Coronary Guide Wire and ViperSlide Lubricant
Cardiovascular Systems, Inc.
St. Paul, MN
55112
Change to the incoming quality control inspection for the saline sheath on the Orbital Atherectomy Device (OAD).
P130009/S009
9/30/14
Edwards Novaflex + Delivery System and
Edwards Ascendra + Delivery System
Edwards Lifesciences, LLC
Irvine, CA
92614
Reduce the post-sterilization ambient aeration hold time for the Edwards Novaflex+ Delivery System and the Edwards Ascendra+ Delivery System.
P130009/S010
9/29/14
Edwards Sapien XT Transcatheter Heart Valve Edwards Lifesciences, LLC
Irvine, CA
92614
Addition of a new clean room and equipment.
P130021/S006
9/9/14
AccuTrak Delivery Catheter System,
Compression Loading System
Medtronic CoreValve, LLC
Santa Rosa, CA 95403
Change to bioburden testing methods.
P130030/S003
9/12/14
REBEL Platinum Chromium Coronary Stent System Boston Scientific Maple Grove, MN 55311 Changes to the inspection of inner subassemblies on the Stent Delivery Catheters.

Summary of PMA Originals & Supplements Approved

  • Originals: 0
  • Supplements: 77

Summary of PMA Originals Under Review

  • Total Under Review: 54
  • Total Active: 26
  • Total On Hold: 28

Summary of PMA Supplements Under Review

  • Total Under Review: 612
  • Total Active: 489
  • Total On Hold: 123

Summary of All PMA Submissions

  • Originals: 1
  • Supplements: 66

Summary of PMA Supplement PMA Approval/Denial Decision Times

  • Number of Approvals: 77
  • Number of Denials: 0
  • Average Days Fr Receipt to Decision (Total Time): 130
  • FDA Time: 103.5 Days
  • MFR Time: 22.5 Days

Page Last Updated: 01/26/2016
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