September 2014 PMA Approvals
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
PMA Original Approvals: None
PMA Supplemental Approvals:
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. |
