PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P130017 8/11/14 |
Cologuard™ | Exact Sciences, Inc. Madison, WI 53719 |
Approval for the Cologuard. Cologuard is intended for the qualitative detection of colorectal neoplasia associated DNA markers and for the presence of occult hemoglobin in human stool. A positive result may indicate the presence of colorectal cancer (CRC) or advanced adenoma (AA) and should be followed by diagnostic colonoscopy. Cologuard is indicated to screen adults of either sex, 50 years or older, who are at typical average-risk for CRC. Cologuard is not a replacement for diagnostic colonoscopy or surveillance colonoscopy in high risk individuals. |
| P130020 8/26/14 |
SenoClaire | General Electric Company – GE Healthcare Waukesha, WI 53188 |
Approval for the SenoClaire. This device is indicated for the acquisition of 2D images and also for the acquisition of multiple projection views intended to produce 3D DBT images suitable for screening and diagnosis of breast cancer. SenoClaire can be used for the same clinical applications as traditional mammography for screening mammography. A screening examination will consist of: 1) 2D image set consisting of a craniocaudal view and of a mediolateral oblique view, or 2) a 2D craniocaudal view and 3D mediolateral oblique image set. The SenoClaire Digital Breast Tomosynthesis (DBT) option to Senographe Essential FFDM system may also be used for additional diagnostic workup of the breast. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| N16837/S014 8/15/14 Real-Time |
Artegraft Collagen Vascular Graft | Artegraft, Inc. North Brunswick, NJ 08902 |
Approval for removal of the Artegraft Culture Tube Injection Blow Mold “Transfer Bead.” |
| P800036/S038 8/1/14 180-Day |
INFUSAID MODEL 400 IMPLANTABLE INFUSION PUMP | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval for an alternate sterilization site located at STERIS-Isomedix (Steris) in Northborough, Massachusetts. |
| 8/29/14 P820003/S103 Real-Time |
DUAL CHAMBER, IMPLANTABLE PULSE GENERATOR | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the qualification of sterilization parameters for the referenced surgical cables and accessories. |
| P830055/S146 8/8/14 Special |
LCS® Total Knee System | DePuy Orthopaedics, Incorporated Warsaw, IN 46581 |
Approval for an additional inspection step in the Model Creation Process for the TruMatch Resection Guides. |
| P830055/S147 8/29/14 Special |
LCS® Total Knee System | DePuy Orthopaedics, Incorporated Warsaw, IN 46581 |
Approval for changes to the labeling for the Computer Aided Surgical Instruments Surgical Technique, including updated illustrations, clarifications of several steps in the technique, and additional instructions for optional use of a lamina spreader technique for soft tissue balancing. |
| P860004/S210 8/14/14 Special |
Synchromed II Implantable Infusion System | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for priming bolus labeling updates. |
| P860057/S118 8/4/14 135-Day |
Carpentier-Edwards PERIMOUNT Pericardial Aortic and Mitral Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for a change in the sanitation frequency of the process water system used at one of the manufacturing facilities. |
| P860057/S126 8/11/14 Real-Time |
Carpentier-Edwards Perimount Magna Pericardial Aortic Bioprosthesis | Edwards Lifesciences, LLC Irvine, CA 92614 |
Approval for a reconfiguration of valve stents, wireforms, and leaflet assemblies, as well as modifications to the labeling. |
| P890003/S314 8/29/14 Real-Time |
MYCARELINK SMART MONITOR AND THE MYCARELINK HEART APPLICATION | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the qualification of sterilization parameters for the referenced surgical cables and accessories. |
| P900056/S132 8/1/14 180-Day |
Rotablator™ Rotational Atherectomy System | Boston Scientific Corporation Natick, MA 01760 |
Approval for component and manufacturing process changes to the Rotablator Console and Dynaglide Foot Pedal. |
| P910023/S339 8/1/14 Real-Time |
Ellipse DR and Ellipse VR ICDs | St. Jude Medical Sylmar, CA 91342 |
Approval for design modifications to the high voltage capacitors utilized in the devices. |
| P910056/S017 8/1/14 180-Day |
enVista® One Piece Hydrophobic Acrylic Lens | Bausch and Lomb Irvine, CA 92618 |
Approval for a packaging change and an extension of the shelf life of the device in the new packaging configuration from 14 to 36 months. |
| P910077/S144 8/12/14 Real-Time |
VENTAK PRX AND VENTAK MINI SYSTEMS | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for Model 2909 Multiple Application Utility System Software v9.03 and Model 2905 PDF Report Generation Software v1.02 which reside on the ZOOM Latitude Programming System Model 3120. |
| P940015/S029 8/6/14 135-Day |
Synvisc/Synvisc-One | Genzyme Corporation Cambridge, MA 02142 |
Approval for changes to the quality control test methods. |
| P940015/S033 8/21/14 Special |
Synvisc® and Synvisc One® | Genzyme Corporation Cambridge, MA 02142 |
Approval for the updating of the package insert and patient information leaflet with respect to adverse event information on pseudosepsis, allergic reactions, and hypersensitivity. |
| P960009/S201 8/29/14 Special |
Activa Deep Brain Stimulator (DBS) Systems | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for a visual inspection change for the DBS boot component in the DBS extension and accessory kits (Models 7482A, 7483, 37085, and 37086). |
| P960016/S047 8/22/14 Real-Time |
Livewire TC™ Cardiac Ablation Catheter System | St. Jude Medical St. Paul, MN 55117 |
Approval for a change from the current Mylar front panel packaging pouch material to Biax Nylon front panel packaging pouch material for the currently approved Livewire TC Ablation Catheter. |
| P960040/S320 8/26/14 Real-Time |
DYNAGEN EL ICD, DYNAGEN MINI ICD, INOGEN EL ICD, INOGEN MINI ICD, ORIGEN EL ICD, ORIGEN MINI ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Approval for minor design changes to the transformer used in the NG3 family of devices. |
| P990081/S029 8/6/14 180-Day |
PATHWAY anti-HER2/neu (4B5) Rabbit Monoclonal Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85755 |
Approval for addition of the facility at Roche in Penzberg, Germany for manufacturing the raw material (antibody) for the PATHWAY anti-HER-2/neu (4B5) Rabbit Monoclonal Primary Antibody employing a different cell culture media. |
| P000006/S036 8/25/14 135-Day |
Titan Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Approval for to use a new vendor/ additional supplier and a new mold. |
| P000006/S037 8/13/14 Special |
Titan Inflatable Penile Prosthesis | Coloplast Corporation Minneapolis, MN 55411 |
Approval for revisions in the Titan Instructions for Use to have “Patients with a documented sensitivity to silicone” as a contraindication instead of being listed as a warning. |
| P010012/S359 8/26/14 Real-Time |
DYNAGEN CRT-D, DYNAGEN X4 CRT-D, INOGEN CRT-D, INOGEN X4 CRT-D, ORIGEN CRT-D, ORIGEN X4 CRT-D |
Boston Scientific Corporation St. Paul, MN 55112 |
Approval for minor design changes to the transformer used in the NG3 family of devices. |
| P020045/S055 8/27/14 Real-Time |
7F Freezor Cardiac CryoAblation Catheter and Cryoconsole, 7F Freezor Xtra Surgical Device and Cryoconsole, and 9F Freezor MAX Surgical Catheter and Cryoconsole |
Medtronic CryoCath LP Mounds View, MN 55112 |
Approval for updates to the blood board and electrical umbilical cable. |
| P020045/S057 8/7/14 Real-Time |
Freezor Cardiac CryoAblation Catheter, Freezor Xtra Surgical Cardiac CryoAblation Device, Freezor MAX Surgical Cardiac CryoAblation Device | Medtronic, Inc. Mounds View, MN 55112 |
Approval for minor labeling changes for the Freezor family of devices- to comply with IEC 6060-1 3RD Edition (E.G., Symbols, storage and Transit Temperatures and Humidity limitation) and add adverse event information. |
| P030017/S152 8/26/14 Real-Time |
Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation (BSN) Valencia, CA 91355 |
Approval for the addition of the CoverEdge 4×8 Surgical Lead (also referred to as the 32 Contact Paddle Lead) and Paddle Blanks to be used with the Precision Spectra Spinal Cord Stimulation System. |
| P030017/S198 8/6/14 Real-Time |
Precision Spectra™ Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation (BSN) Corporation Valencia, CA 91355 |
Approval for a design change to the Application Specific Integrated Circuit (ASIC) on the Ball Grid Array (BGA) component. |
| P030017/S201 8/28/14 Real-Time |
Boston Scientific Precision Spectra™ Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Valencia, CA 91355 |
Approval for a change to the Precision Spectra Observational Mechanical Gateway (OMG) Directions For Use. The proposed change is to add the St Jude Penta Lead (Model # 3228) to the table of compatible St. Jude leads in the Directions For Use. In addition, a statement was added to the Intended Use section to refer to the Precision Spectra System manuals for the indications and contraindications. |
| P030032/S016 8/6/14 135-Day |
PREVELLE Silk | Genzyme Corporation Cambridge, MA 02142 |
Approval for changes to the quality control test methods. |
| P040002/S053 8/12/14 Special |
AFX Vela Proximal Endograft System | Endologix, Inc. Irvine, CA 92618 |
Approval for an additional in –process x-ray inspection step. |
| P040033/S025 8/12/14 Real-Time |
Birmingham Hip Resurfacing (BHR) System | Smith & Nephew, Incorporated Cordova, TN 38016 |
Approval for an addition to the labeling for the Birmingham Hip Resurfacing (BHR) System to include MR Conditional language in the Warnings and Precautions for the system. |
| P040036/S043 8/1/14 180-Day |
NaviStar ThermoCool, EZ Steer ThermoCool Nav, NaviStar RMT ThermoCool, and ThermoCool SmartTouch Catheters |
Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for updates to the Instructions for Use of the Post Approval Study results on the NaviStar ThermoCool catheter for VT condition. |
| P040044/S057 8/18/14 Real-Time |
Mynx Ace Vascular Closure Device | Access Closure, Inc. Santa Clara, CA 95054 |
Approval for a modified packaging tray, removal of the guidewire and J-straightener, and updated IFU to remove references to the provided guidewire and J-straightener. |
| P050010/S016 8/27/14 135-Day |
Synthes ProDisc-C and ProDisc L Total Disc Replacement Devices | Depuy Synthes Spine Raynham, MA 02767 |
Approval for a change to the method used for establishment of the bioburden alert and action levels for dose auditing of Synthes ProDisc-C and ProDisc-L Total Disc Replacement devices. |
| P060002/S034 8/13/14 180-Day |
FLAIR® Endovascular Stent Graft | Bard Peripheral Vascular, Inc. Tempe, AZ 85281 |
Approval for updated Instructions for Use (IFU) to include data from the postapproval study (RENOVA). |
| P060037/S021 8/11/14 135-Day |
LPS-Flex Mobile and LPS-Mobile Bearing Knee System | Zimmer, Inc. Warsaw, IN 46581 |
Approval for elimination of an incremental re-verification step. |
| P060037/S030 8/14/14 180-Day |
Legacy Knee-Posterior Stabilized (LPS), Flex Mobile Bearing Knee System | Zimmer, Inc. Warsaw, IN 46581 |
Approval of the post-approval study protocol. |
| P060039/S056 8/4/14 180-Day |
Attain StarFix LV Lead | Medtronic CRDM Mounds View, MN 55112 |
Approval for post approval summary labeling for the Attain StarFix LV Lead Extraction study. |
| P060040/S031 8/5/14 180-Day |
Thoratec HeartMate II Left Ventricular Assist System (LVAS) | Thoratec Corporation Pleasanton, CA 94588 |
Approval for updating the HeartMate II LVAS Instructions for Use to include the post-approval study results for the destination therapy indication and to add a discussion on pump thrombosis. |
| P070001/S013 8/27/14 135-Day |
Synthes ProDisc-C and ProDisc L Total Disc Replacement Devices | Depuy Synthes Spine Raynham, MA 02767 |
Approval for a change to the method used for establishment of the bioburden alert and action levels for dose auditing of Synthes ProDisc-C and ProDisc-L Total Disc Replacement devices. |
| P080006/S068 8/1/14 180-Day |
Attain Performa™ Left Ventricular Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the Attain Performa Model 4298 Left Ventricular Lead, indicated for chronic pacing in the left ventricle via the cardiac vein, when used with a compatible Medtronic Cardiac Resynchronization Therapy (CRT) system. |
| P090018/S026 8/21/14 Real-Time |
Envoy Esteem | Envoy Medical Corporation Saint Paul, MN 55110 |
Approval for software changes that have been made to the Esteem Commander in version 3.0. |
| P100010/S037 8/27/14 Real-Time |
Arctic Front Cardiac CryoAblation Catheters, Freezor MAX CryoAblation Catheter, Cryoconsole, Manual Retraction Kit, and Accessories |
Medtronic CryoCath LP Mounds View, MN 55112 |
Approval for updates to the blood board and electrical umbilical cable. |
| P100010/S039 8/7/14 Real-Time |
Freezor MAX Cardiac CryoAblation Catheter | Medtronic, Inc. Mounds View, MN 55112 |
Approval for minor labeling changes for the Freezor family of devices-to comply with IEC 6060-1 3rd edition (e.g., symbols, storage and transit temperatures, and humidity limitation) and add adverse event info. |
| P100014/S014 8/28/14 135-Day |
Solesta | Salix Pharmaceuticals, Inc. Raleigh, NC 27615 |
Approval for a change of the manufacturer of needles that are supplied with the Solesta device. |
| P100023/S076 8/28/14 180-Day |
ION Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval of the post-approval study protocol. |
| P100041/S056 8/28/14 180-Day |
Edwards SAPIEN Transcatheter Heart Valve with Retroflex (transfemoral delivery) and Ascendra (transapical delivery) | Edwards Lifesciences, LLC. Irvine, CA 92614 |
Approval of the post-approval study protocol. |
| P100045/S001 8/29/14 180-Day |
CardioMEMS HF System | St. Jude Medical, Inc. Atlanta, GA 30313 |
Approval of the post-approval study protocol. |
| P100047/S040 8/25/14 180-Day |
HeartWare® Ventricular Assist System | Heartware, Inc. Miami Lakes, FL 33014 |
Approval for changing the AC and DC Adaptors Output cabling sheath and over-mold material as well as the number of conductor wires. |
| P110042/S029 8/22/14 180-Day |
Cameron Health Subcutaneous Implantable Defibrillator S-ICD System | Boston Scientific St. Paul, MN 55112 |
Approval for the Software Maintenance Release 8. |
| P120010/S005 8/21/14 |
MiniMed 530G System | Medtronic Minimed Northridge, CA 91325 |
Approval for the implementation of a pneumatic press tool in place of a manual press tool in the manufacturing process of the Paradigm REAL-Time Insulin Pump (Models:MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm REAL-Time Revel Insulin-Pump (Models: MMT-523, MMT-523K, MMT-723, MMT-723K), Guardian REALTime Monitor (Models: CSS7100 and CSS17100K) and the MiniMed 530G Insulin Pump (Models: MMT-551 and MMT-751). These parts are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time Continuous Glucose Monitoring Systems and the MiniMed 530G System respectively. |
| P120009/S001 8/1/14 180-Day |
Nit-Occluder PDA | PFM Medical, Inc. Carlsbad, CA 92008 |
Approval of the post-approval study protocol. |
| P130021/S005 8/12/14 Real-Time |
Medtronic CoreValve System | Medtronic Core Valve Santa Rosa, CA 95403 |
Approval for use of an alternative end seal label. |
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 |
|---|---|---|---|
| N16837/S017 8/25/14 |
Artegraft Collagen Vascular Graft | Artegraft, Inc. North Brunswick, NJ 08902 |
Alternate supplier for the bovine carotid artery. |
| N18033/S074 8/14/14 |
VISTAKON® Etafilcon A | Johnson and Johnson Vision Care, Inc. Jacksonville, FL 32256 |
Addition of a quality control sampling plan. |
| P790007/S043 8/14/14 |
Hancock® Modified Orifice Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
| P810025/S035 8/29/14 |
Amvisc and Amvisc Plus Ophthalmic Viscosurgical Device (OVD) | Bausch and Lomb Inc. Irvine, CA 92618 |
Elimination of post-fill quality control tests. |
| P830061/S110 8/8/14 |
CapSure Sense Leads | Medtronic, Inc. Mounds View, MN 55112 |
New fixture for the pull testing at MSO for the devices. |
| P830061/S111 8/12/14 |
CapSure SP Novus Lead, Vitatron Excellence PS+ Lead | Medtronic Inc. Mounds View, MN 55112 |
Transfer of component manufacturing to a different internal supplier for the two MCRD (monolithic controlled release device) components used in the cardiac lead models. |
| P830061/S112 8/20/14 |
CAPSURE SENSE LEAD, CAPSURE SP LEAD, CAPSURE SP NOVUS LEAD, VITATRON CRYSTALLINE LEAD, VITATRON EXCELLENCE PS+ LEAD |
Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P830061/S113 8/29/14 |
CapSure Sense Leads, CapSure SP Novus Leads, Vitatron Crystalline Leads, Vitatron Excellence PS+ Leads |
Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices. |
| P840001/S275 8/1/14 |
SCS Neurostimulators Implantable Itrel Family, SCS Neurostimulators Implantable Restore Family, SCS Neurostimulators Implantable Synergy Family | Medtronic, Inc. Minneapolis, MN 55432 |
Addition of new welding equipment. |
| P840001/S276 8/1/14 |
SCS Neurostimulators Implantable Itrel Family, SCS Neurostimulators Implantable Restore Family, SCS Neurostimulators Implantable Synergy Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add additional processing equipment. |
| P840001/S277 8/8/14 |
Injex Anchor Kits | Medtronic, Inc. Minneapolis, MN 55432 |
Changes to the sealing process equipment. |
| P840001/S278 8/19/14 |
Itrel Spinal Cord Stimulation System – Anchor Deployment Tool System | Medtronic, Inc. Minneapolis, MN 55432 |
Manufacturing changes to the cavity molds. |
| P840001/S279 8/27/14 |
SCS Implantable Neurostimulators Itrel Family, SCS Implantable Neurostimulators Synergy Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add an alternate supplier and to make manufacturing tooling changes for a component of the feedthrough assembly. |
| P840001/S280 8/27/14 |
SCS Neurostimulators Implantable Itrel Family, SCS Neurostimulators Implantable Restore Family, SCS Neurostimulators Implantable Synergy Family | Medtronic, Inc. Minneapolis, MN 55432 |
Update and implement a serial number generator. |
| P850007/S033 8/27/14 |
Physio-Stim and Spinal-Stim | Orthofix Lewisville, TX 75056 |
Process change for the bone growth stimulator devices. |
| P850022/S023 8/28/14 |
Biomet OrthoPak Non-invasive Bone Growth Stimulator System & Biomet SpinalPak Non-invasive Spine Fusion Stimulator System | EBI, LLC, d/b/a Biomet Spine & Bone Healing Technologies Parsippany, NJ 07054 |
PCB board and software changes. |
| P850089/S108 8/12/14 |
CapSure Z Novus Lead, Vitatron Impulse II Lead, CapSure SP Novus Lead | Medtronic Inc. Mounds View, MN 55112 |
Transfer of component manufacturing to a different internal supplier for the two MCRD (monolithic controlled release device) components used in the cardiac lead models. |
| P850089/S109 8/20/14 |
CAPSURE SP NOVUS LEAD, CAPSURE SP Z LEAD, CAPSURE Z NOVUS LEAD, VITATRON IMPULSE II LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P850089/S110 8/29/14 |
CapSure SP Novus Leads, CapSure Z Novus Leads | Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices. |
| P860003/S076 8/21/14 |
Therakos UVAR XTS and CELLEX Photopheresis Systems | Therakos Inc. Bridgewater, NJ 08807 |
Supplier change for a component of the Light Assemblies used in Therakos UVAR XTS and CELLEX Photopheresis Systems. |
| P870078/S027 8/14/14 |
Hancock® Low Porosity Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
| P890003/S312 8/12/14 |
CapSure VDD-2 Lead, Vitatron Brilliant S+ VDD Lead | Medtronic Inc. Mounds View, MN 55112 |
Transfer of component manufacturing to a different internal supplier for the two MCRD (monolithic controlled release device) components used in the cardiac lead models. |
| P890003/S315 8/20/14 |
CAPSURE VDD 2, VITATRON BRILLIANT S+ VDD LEAD, VITATRON BRILLIANT S+ VDD LEAD |
Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P890003/S316 8/29/14 |
Prodigy IPG | Medtronic Inc. Mounds View, MN 55112 |
Manufacturing tooling update and an additional supplier for the insulator subcomponent of the Flat Top (FT) assembly of the devices. |
| P890003/S317 8/29/14 |
CapSure VDD 2 | Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices. |
| P900009/S037 8/21/14 |
EXOGEN Ultrasound Bone Healing System | Bioventus LLC. Durham, NC 27703 |
Movement of the manufacturing process of a component to a new facility. |
| P900056/S142 8/1/14 |
Rotablator Rotational Atherectomy System | Boston Scientific Corp Maple Grove, MN 55311 |
Removal of redundant incoming acceptance testing. |
| P900061/S130 8/20/14 |
END CAP, EPICARDIAL PATCH LEAD, UPSIZING SLEEVE | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P910001/S073 8/21/14 |
CVX-300 and CVX-300-P Excimer Laser System | Spectranetics Corporation Colorado Springs, CO 80921 |
Add alternate suppliers for a capacitor component of the CVX-300 and CVX-300-P laser systems. |
| P920015/S135 8/8/14 |
Sprint Quattro Leads | Medtronic, Inc. Mounds View, MN 55112 |
Add a new component supplier. |
| P920015/S136 8/20/14 |
DF-1 CONNECTOR PORT PIN PLUG, HV SPLITTER/ ADAPTOR KIT, LEAD ADAPTOR, SPRINT QUATTRO LEAD, TRANSVENE CS/SVC LEAD |
Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P920015/S137 8/14/14 |
Sprint Quattro Leads | Medtronic, Inc. Mounds View, MN 55112 |
Minor change to the plasma treatment process used on silicone tubing. |
| P920015/S138 8/29/14 |
Sprint Quattro Leads, Subcutaneous Leads | Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices. |
| P920015/S139 8/27/14 |
HV Splitter/Adaptor Kit, Sprint Quattro Leads, Subcutaneous Lead, Transvene CS/SVC Lead |
Medtronic, Inc. Mounds View, MN 55112 |
Outsource two molded components. |
| P930039/S112 8/8/14 |
CapSureFix Novus Leads | Medtronic, Inc. Mounds View, MN 55112 |
New fixture for the pull testing at MSO for the devices. |
| P930039/S113 8/20/14 |
CAPSUREFIX LEAD, SUREFIX LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P930039/S114 8/14/14 |
CapSureFix Lead, SureFix Lead | Medtronic, Inc. Mounds View, MN 55112 |
Minor change to the plasma treatment process used on silicone tubing. |
| P930039/S115 8/29/14 |
CapSureFix Leads, CapSureFix Novus Leads, Vitatron Crystalline Active Fixation Leads |
Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices. |
| P950020/S068 8/29/14 |
Flextome® Cutting Balloon® Microsurgical Dilatation Device | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to move the electrical discharge machining (EDM) process for a component of the BSC Flextome Cutting Balloon Microsurgical Dilatation Device to the BSC Maple Grove, Minnesota facility. |
| P950024/S060 8/12/14 |
CapSure Epicardial Pacing Lead | Medtronic Inc. Mounds View, MN 55112 |
Transfer of component manufacturing to a different internal supplier for the two MCRD (monolithic controlled release device) components used in the cardiac lead models. |
| P950024/S061 8/20/14 |
CAPSURE EPICARDIAL PACING LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P950029/S093 8/12/14 |
Reply SR, Reply DR, Espirit SR, Espirit DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Update of the in-process steps on the electronic assembly line. |
| P950029/S094 8/27/14 |
REPLY SR, REPLY DR, ESPRIT SR, ESPRIT DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Alternate thermosealing equipment to perform blister sealing operation for pacemakers and defibrillators. |
| P950029/S095 8/27/14 |
Reply SR, Reply DR, Esprit SR, and Esprit DR Pacemakers | Sorin CRM USA, Inc. Arvada, CO 80004 |
Changes on the electronic assembly line for an update to in-process steps. |
| P950034/S042 8/12/14 |
Seprafilm Adhesion Barrier | Genzyme Corporation Framingham, MA 01701 |
Additional site for quarterly irradiation dose verification for the Seprafilm Adhesion Barrier. |
| P960009/S198 8/1/14 |
DBS Neurostimulators Implantable Activa Family, DBS Neurostimulators Implantable Kinetra Family | Medtronic, Inc. Minneapolis, MN 55432 |
Addition of new welding equipment. |
| P960009/S199 8/1/14 |
DBS Neurostimulators Implantable Activa Family, DBS Neurostimulators Implantable Kinetra Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add additional processing equipment. |
| P960009/S202 8/27/14 |
DBS Neurostimulators Implantable Activa Family, DBS Neurostimulators Implantable Kinetra Family | Medtronic, Inc. Minneapolis, MN 55432 |
Update and implement a serial number generator. |
| P960009/S210 8/27/14 |
DBS Implantable Neurostimulators Activa Family, DBS Implantable Neurostimulators Kinetra Family, DBS Implantable Neurostimulators Soletra Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add an alternate supplier and to make manufacturing tooling changes for a component of the feedthrough assembly. |
| P960011/S026 8/12/14 |
BVI 1% OVD | Ferring Pharamceuticals, Inc. Parsippany, NJ 07054 |
Addition of a new automated thermoforming machine and packaging process. |
| P960040/S325 8/11/14 |
NG2.5 Implantable Cardiac Defibrillator (ICD) Family | Boston Scientific Corporation Saint Paul, MN 55112 |
Manufacture the battery feedthru subassembly at the St. Paul facility for the devices. |
| P960040/S326 8/13/14 |
NG3 Devices, Origen ICDs, Inogen ICDs, Dynagen ICDs, Progeny Devices, Punctua ICDs, Energen ICDs, Incepta ICDs |
Boston Scientific Corporation St. Paul, MN 55112 |
Add a second-tier supplier for Silicon-Controlled Rectifiers (SCRs) and Anode Gated Thyristors (AGTs). |
| P960040/S328 8/27/14 |
Teligen ICD, Incepta ICD, Energen ICD, Punctua ICD, Dynagen ICD, Inogen ICD, Origen ICD | Boston Scientific Corporation St. Paul, MN 55112 |
Modify a vacuum bake process. |
| P970004/S180 8/1/14 |
SNS Urinary Neurostimulator Implantable InterStim Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add additional processing equipment. |
| P970004/S181 8/27/14 |
SNS Urinary Implantable Neurostimulators InterStim Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add an alternate supplier and to make manufacturing tooling changes for a component of the feedthrough assembly. |
| P970004/S182 8/27/14 |
SNS Urinary Neurostimulator Implantable InterStim Family | Medtronic, Inc. Minneapolis, MN 55432 |
Update and implement a serial number generator. |
| P970031/S047 8/14/14 |
Freestyle® Aortic Root Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
| P970051/S122 8/22/14 |
Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 |
Acceptance of a new quality control test system. |
| P980016/S493 8/15/14 |
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 |
Change of a cleaning chemical used in the manufacture of the flex circuit component used in the devices. |
| P980016/S494 8/20/14 |
EVERA, MAXIMO II, PROTECTA, SECURA, VIRTUOSO II ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P980016/S495 8/13/14 |
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 |
Use a new software version to collect measurement and process data at the hybrid supplier. |
| P980016/S496 8/27/14 |
Maximo ICD, Protecta ICD, Protecta XT ICD, Secura ICD, Virtuoso II DR/VR ICD | Medtronic, Inc. Mounds View, MN 55112 |
Automate the in-process battery insulator inspection. |
| P980022/S147 8/21/14 |
Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REALTime Continuous Glucose Monitoring Systems |
Medtronic Minimed Northridge, CA 91325 |
Approval for the implementation of a pneumatic press tool in place of a manual press tool in the manufacturing process of the Paradigm REAL-Time Insulin Pump (Models:MMT-522, MMT-522K, MMT-722, MMT-722K), Paradigm REAL-Time Revel Insulin-Pump (Models: MMT-523, MMT-523K, MMT-723, MMT-723K), Guardian REALTime Monitor (Models: CSS7100 and CSS17100K) and the MiniMed 530G Insulin Pump (Models: MMT-551 and MMT-751). These parts are components of the Paradigm REAL-Time System, Paradigm REAL-Time Revel System, Guardian REAL-Time Continuous Glucose Monitoring Systems and the MiniMed 530G System respectively. |
| P980035/S385 8/13/14 |
Adapta, Versa, Sensia IPG | Medtronic CRDM Mounds View, MN 55112 |
Resin and catalyst pressure range changes of the epoxy dispense for the devices. |
| P980035/S386 8/20/14 |
ADAPTA, VERSA, SENSIA IPG | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P980035/S387 8/15/14 |
Advisa DR IP, Advisa DR MRI IPG, Adapta, Versa, Sensia IPG, Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Allowance of room temperature testing at final functional testing specific process flows. |
| P980035/S388 8/13/14 |
Adapta/Versa/Sentia IPG, Advisa DR IPG, Advisa DR MRI IPG, Relia IPG | Medtronic, Inc. Mounds View, MN 55112 |
Use a new software version to collect measurement and process data at the hybrid supplier. |
| P980035/S389 8/29/14 |
Adapta, Versa, Sensia, Advisa DR, Advisa DR MRI, Relia IPGs | Medtronic Inc. Mounds View, MN 55112 |
Manufacturing tooling update and an additional supplier for the insulator subcomponent of the Flat Top (FT) assembly of the devices. |
| P980043/S049 8/14/14 |
Hancock® II Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
| P990046/S038 8/20/14 |
Open Pivot Heart Valve and Open Pivot Aortic Valved Graft | Medtronic Inc. Mounds View, MN 55112 |
Alternate vision system for in-process inspection of leaflet components. |
| P980049/S101 8/27/14 |
PARADYM VR, PARADYM DR, PARADYM RF VR, PARADYM RF DR | Sorin CRM USA, Inc. Arvada, CO 80004 |
Alternate thermosealing equipment to perform blister sealing operation for pacemakers and defibrillators. |
| P980050/S093 8/20/14 |
TRANSVENE CS/SVC LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P980050/S094 8/29/14 |
Transvene CS/SVC Leads | Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices. |
| P980050/S095 8/27/14 |
Transvene CS/SVC Lead | Medtronic, Inc. Mounds View, MN 55112 |
Outsource two molded components. |
| P990064/S058 8/14/14 |
Mosaic® Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 |
Addition of a new porcine tissue supplier. |
| P990075/S026 8/12/14 |
Mentor Corporation Saline-Filled and SPECTRUM Mammary Prostheses | MENTOR Worldwide LLC c/o Ethicon, Inc. Somerville, NJ 08879 |
Change the supplier of an additive and replace the additive with another version of the same material. |
| P010012/S356 8/13/14 |
NG3 Devices: Origen CRT-Ds, Inogen CRT-Ds, Dynagen CRT-Ds, Progeny Devices, Punctua CRT-Ds, Energen CRT-Ds, Incepta CRT-Ds |
Boston Scientific Corporation St. Paul, MN 55112 |
Add a second-tier supplier for Silicon-Controlled Rectifiers (SCRs) and Anode Gated Thyristors (AGTs). |
| P010012/S365 8/15/14 |
ACUITY SPIRAL, EASYTRAK 2 AND 3 LEADS | Boston Scientific Corporation St. Paul, MN 55112 |
Removal of the 36-month shelf life for polyurethane tubing. |
| P010012/S368 8/27/14 |
Cognis CRT-D, 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 |
Modify a vacuum bake process. |
| P010015/S245 8/20/14 |
ATTAIN BIPOLAR LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P010015/S246 8/13/14 |
Consulta CRT-P, Syncra CRT-P, Viva CRT-P | Medtronic, Inc. Mounds View, MN 55112 |
Use a new software version to collect measurement and process data at the hybrid supplier. |
| P010015/S247 8/29/14 |
Attain Bipolar OTW Leads, Left Ventricular Pacing Leads | Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices. |
| P010030/S055 8/7/14 |
LifeVest® Wearable Defibrillator | ZOLL Lifecor Corporation Pittsburgh, PA 15238 |
Change in the in-process testing of the LifeVest® Wearable Defibrillator. |
| P010031/S456 8/15/14 |
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta ICD, 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 |
Change of a cleaning chemical used in the manufacture of the flex circuit component used in the devices. |
| P010031/S457 8/20/14 |
BRAVA, CONCERTO II, CONSULTA, MAXIMO II, PROTECTA, AND VIVA CRT-DEFIBRILLATORS |
Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P010031/S458 8/12/14 |
Viva/Brava Quad CRT-Ds | Medtronic Inc. Mounds View MN, 55112 |
Addition of Fill Hole Seal Laser Welding equipment. |
| P010031/S459 8/13/14 |
Brava CRT-D, Brava Quad CRT-D, Concerto II CRT-D, Consulta ICD, 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 | Medtronic, Inc. Mounds View, MN 55112 |
Use a new software version to collect measurement and process data at the hybrid supplier. |
| P010031/S460 8/27/14 |
Concerto IICRT-D, Consulta CRT-D, Maximo II CRT-D, Protecta CRT-D, Protecta XT CRT-D | Medtronic, Inc. Mounds View, MN 55112 |
Automate the in-process battery insulator inspection. |
| P020004/S103 8/22/14 |
Excluder AAA Endoprosthesis | W.L. Gore & Associates Phoenix, AZ 85085 |
Add the capability for catheter component manufacturing at an additional internal facility. |
| P030011/S026 8/7/14 |
SynCardia temporary Total Artificial Heart (TAH-t) | SynCardia Systems, Inc. Tucson, AZ 85713 |
New supplier for the Freedom Driver System battery. |
| P030034/S007 8/27/14 |
Cervical-Stim | Orthofix Lewisville, TX 75056 |
Process change for the bone growth stimulator devices. |
| P030036/S072 8/20/14 |
ANCORING SLEEVE KIT, SELECTSECURE LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P030036/S073 8/29/14 |
SelectSecure Leads | Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices |
| P030052/S016 8/14/14 |
UroVysion Bladder Cancer Kit | Abbott Molecular, Inc. Des Plains, IL 60018 |
Replacement of the fermenters used in the fermentation processes. |
| P040020/S055 8/20/14 |
AcrySof® ReSTOR Multifocal Posterior Intraocular | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Change in calculation method for a quality control test. |
| P040045/S046 8/14/14 |
VISTAKON® Senofilcon A, VISTAKON® Etafilcon A |
Johnson and Johnson Vision Care Incorporated Jacksonville, FL 32256 |
Addition of a quality control sampling plan. |
| P050017/S010 8/14/14 |
Zilver Vascular Stent | Cook Incorporated Bloomington, IN 47402 |
Add a manufacturing step to the handle assembly of the delivery system. |
| P050027/S006 8/7/14 |
KARL STORZ Photodynamic D-Light C (PDD) System | Karl Storz Endoscopy El Segundo, CA 90245 |
Incorporate new electrical safety testing equipment to replace older equipment. |
| P050037/S051 8/20/14 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Changes to the autoclave control mechanism and preparation of load probes for the equipment sanitization cycle associated with the Radiesse Dermal Filler. |
| P050037/S052 8/19/14 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Relocation of the Quality Incoming Inspection Lab, installation of the QC Clean Room and installation of an automated temperature/ humidity monitoring system. |
| P050037/S053 8/25/14 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Changes related to the raw material used in the production of calcium hydroxylapatite (CaHA) component. |
| P050046/S024 8/15/14 |
ACUITY STEERABLE LEADS | Boston Scientific Corporation St. Paul, MN 55112 |
Removal of the 36-month shelf life for polyurethane tubing. |
| P050052/S056 8/20/14 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Changes to the autoclave control mechanism and preparation of load probes for the equipment sanitization cycle associated with the Radiesse Dermal Filler. |
| P050052/S057 8/19/14 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Relocation of the Quality Incoming Inspection Lab, installation of the QC Clean Room and installation of an automated temperature/ humidity monitoring system. |
| P050052/S058 8/25/14 |
Radiesse Dermal Filler | Merz North America, Inc. Franksville, WI 53126 |
Changes related to the raw material used in the production of calcium hydroxylapatite (CaHA) component. |
| P060001/S022 8/20/14 |
Protégé GPS and Protégé RX Carotid Stent System | ev3, Inc. Plymouth, MN 55441 |
Change the manual process for measuring stent dimensions to an automated process. |
| P060027/S068 8/27/14 |
PARADYM CRT-D, PARADYM RF CRT-D | Sorin CRM USA, Inc. Arvada, CO 80004 |
Alternate thermosealing equipment to perform blister sealing operation for pacemakers and defibrillators. |
| P060030/S043 8/22/14 |
COBAS® AmpliPrep/ COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System |
Roche Molecular Systems, Incorporated Pleasanton, CA 94588 |
Change to revise the manufacturing release specifications for the positive controls packaged as part of the COBAS® AmpliPrep/COBAS® TaqMan® HCV Test and COBAS® TaqMan HCV Test version 2.0 For Use With The High Pure System. |
| P060039/S060 8/20/14 |
ATTAIN STARFIX LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P060039/S061 8/29/14 |
Attain StarFix Leads, SureFix Leads | Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices. |
| P080006/S069 8/20/14 |
ATTAIN ABILITY LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P080006/S070 8/29/14 |
Attain Ability Leads | Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices. |
| P080020/S009 8/25/14 |
Gel-One | Seikagaku Corporation Tokyo, Japan |
Replace a previous autoclave with a new autoclave. |
| P080020/S010 8/28/14 |
Gel-One | Seikagaku Corporation Tokyo, Japan |
Update a testing system. |
| P080020/S011 8/28/14 |
Gel-One | Seikagaku Corporation Tokyo, Japan |
Use newly installed equipment. |
| P080020/S012 8/28/14 |
Gel-One | Seikagaku Corporation Tokyo, Japan |
Use newly installed equipment. |
| P080025/S076 8/1/14 |
SNS Bowel Neurostimulators Implantable InterStim Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add additional processing equipment. |
| P080025/S077 8/27/14 |
SNS Bowel Implantable Neurostimulators InterStim Family | Medtronic, Inc. Minneapolis, MN 55432 |
Add an alternate supplier and to make manufacturing tooling changes for a component of the feedthrough assembly. |
| P080025/078 8/27/14 |
SNS Bowel Neurostimulators Implantable InterStim Family | Medtronic, Inc. Minneapolis, MN 55432 |
Update and implement a serial number generator. |
| P080030/S011 8/29/14 |
Glaukos® Corporation iStent® Trabecular Micro-Bypass Stent System | Glaukos Corporation Laguna Hills, CA 92653 |
Modification to the etching process consisting of the changes to the etching time, acid concentration, batch size, and agitation method. |
| P090013/S148 8/8/14 |
CapSureFix MRI Lead | Medtronic, Inc. Mounds View, MN 55112 |
New fixture for the pull testing at MSO for the devices. |
| P090013/S150 8/20/14 |
CAPSUREFIX MRI LEAD | Medtronic, Inc. Mounds View, MN 55112 |
Replacement of a manual recording system for monitoring differential pressure with an automated system. |
| P090013/S152 8/29/14 |
CapSureFix MRI Leads | Medtronic, Inc. Mounds View, MN 55112 |
Update to the final packaging line for the devices. |
| P090031/S151 8/13/14 |
Revo MRI IPG | Medtronic, Inc. Mounds View, MN 55112 |
Use a new software version to collect measurement and process data at the hybrid supplier. |
| P100009/S007 8/13/14 |
MitraClip® Clip Delivery System (CDS) | Abbott Vascular Santa Clara, CA 95054 |
Density range changes (for cartons and pallets) and 5 minor process changes as a part of the annual revalidation of sterilization. |
| P100010/S041 8/22/14 |
Arctic Front and Arctic Front Advance Catheters | Medtronic Cryocath LP Mounds View, MN 55112 |
Updates to the manufacturing steps during the heat shrink process for the guide wire lumen in the Arctic Front and Arctic Front Advance catheters. |
| P100010/S042 8/27/14 |
Arctic Front Advance CryoBalloon Catheter | Medtronic AF Solutions Mounds View, MN 55112 |
Updates to the Quality Assurance Final inspection (QA Final) and Final Handle Assembly (P18) to streamline the manufacturing flow, balance the workload, and reduce the cycle time of the final inspection steps of the Arctic Front Advance (AFA) catheters. |
| P100014/S015 8/7/14 |
Solesta | Salix Pharmaceuticals, Inc. Raleigh, NC 27615 |
Introduction of an alternate supplier for two process chemicals used in the bulk manufacturing process of Solesta. |
| P100018/S012 8/20/14 |
Pipeline Embolization Device | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular Irvine, CA 92618 |
Make supplier process changes to the Pipeline Embolization Device. |
| P100023/S103 8/5/14 |
ION (Taxus Element) Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the endotoxin sampling plan. |
| P100026/S023 8/21/14 |
Neuropace RNS System | NeuroPace, Inc. Mountain View, CA 94043 |
Introduce additional equipment for laser marking. |
| P100026/S024 8/22/14 |
Neuropace RNS System | NeuroPace, Inc. Mountain View, CA 94043 |
Modify the Cortical Strip Lead distal assembly molding process. |
| P100041/S054 8/4/14 |
Edwards Balloon Catheter | Edwards Lifesciences, LLC Irvine, CA 92614 |
Modify the sampling plan for routine monitoring of the Edwards Balloon Catheter, Edwards Expandable Introducer Sheath Set, NovaFlex+ Delivery System and Ascendra+ Delivery System. |
| P110010/S091 8/5/14 |
PROMUS Element Plus/PREMIER Everolimus-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to the endotoxin sampling plan. |
| P100047/S048 8/13/14 |
HeartWare Ventricular Assist System | HeartWare, Inc. Miami Lakes, FL 33014 |
Implementation of a new mechanized impeller polishing process. |
| P110012/S008 8/14/14 |
Vysis ALK Break Apart FISH Probe Kit | Abbott Molecular, Inc. Des Plains, IL 60018 |
Replacement of the fermenters used in the fermentation processes. |
| P110021/S041 8/4/14 |
Edwards Balloon Catheter | Edwards Lifesciences, LLC Irvine, CA 92614 |
Modify the sampling plan for routine monitoring of the Edwards Balloon Catheter, Edwards Expandable Introducer Sheath Set, NovaFlex+ Delivery System and Ascendra+ Delivery System. |
| P110023/S006 8/20/14 |
Protégé GPS and Protégé RX Carotid Stent System | ev3, Inc. Plymouth, MN 55441 |
Change the manual process for measuring stent dimensions to an automated process. |
| P110028/S013 8/15/14 |
Absolute Pro Vascular Self-Expanding Stent System | Abbott Vascular Santa Clara, CA 95054 |
Supplier change for the manufacturing of the guidewire lumen. |
| P110035/S028 8/26/14 |
Epic Vascular Self-expanding Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Stent component sub-process relocation. |
| P11042/S040 8/27/14 |
Subcutaneous Implantable Defibrillator (S-ICD) System |
Cameron Health, Inc. St. Paul, MN 55112 |
Manufacturing process change to improve an inspection step. |
| P120005/S027 8/22/14 |
Dexcom G4 PLATINUM Continuous Glucose Monitoring System | Dexcom, Inc. San Diego, CA 92121 |
Relocation of receiving and receiving inspection activities to a new warehouse facility. |
| P120010/S031 8/28/14 |
MiniMed 530G System | Medtronic MiniMed Inc. Northridge, CA 91325 |
Change in the manufacturing of the Enlite™ Glucose Sensor (Model Numbers: MMT-7008A, MMT-7008B) to modify the sterilization process with respect to the sterilization dose and bioburden alert and action levels. The Enlite™ Glucose Sensor is a component of the MiniMed 530G System. |
| P120016/S003 8/7/14 |
VASCADE Vascular Closure System | Cardiva Medical, Inc. Sunnyvale, CA 94085 |
Modification to the processing of a sleeve component. |
| P130009/S001 8/4/14 |
NovaFlex+ Delivery System, Edwards Expandable Introducer Sheath Set, Edwards Balloon Catheter, Ascendra+ Delivery System |
Edwards Lifesciences, LLC Irvine, CA 92614 |
Modify the sampling plan for routine monitoring of the Edwards Balloon Catheter, Edwards Expandable Introducer Sheath Set, NovaFlex+ Delivery System and Ascendra+ Delivery System. |
| P130009/S003 8/7/14 |
SAPIEN XT Transcatheter Heart Valve and Accessories | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of a new sterile wiper for use in cleanrooms and non-controlled environments to clean work surfaces and tools. |
| P130009/S005 8/7/14 |
SAPIEN XT Transcatheter Heart Valve | Edwards Lifesciences, LLC Irvine, CA 92614 |
Addition of a new bovine tissue supplier. |
| P130016/S008 8/22/14 |
Nucleus 24 Hybrid System | Cochlear Americas Centennial, CO 80111 |
Acceptance of a new quality control test system. |
| P130030/S001 8/4/14 |
REBEL Platinum Chromium Coronary Stent System (Monorail™ and Over-The-Wire) | Boston Scientific Corporation Maple Grove, MN 55311 |
Change to add ethylene oxide sterilization chambers to sterilize the subject device. |
| P130030/S002 8/19/14 |
REBEL Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Upgrade to the Manufacturing Execution System (MES). |
Summary of PMA Originals & Supplements Approved
- Originals: 2
- Supplements: 53
Summary of PMA Originals Under Review
- Total Under Review: 53
- Total Active: 30
- Total On Hold: 23
Summary of PMA Supplements Under Review
- Total Under Review: 539
- Total Active: 414
- Total On Hold: 125
Summary of All PMA Submissions
- Originals: 4
- Supplements: 60
Summary of PMA Supplement PMA Approval/Denial Decision Times
- Number of Approvals: 53
- Number of Denials: 0
- Average Days Fr Receipt to Decision (Total Time): 127.3
- Days FDA Time: 93.9
- Days MFR Time: 33.4 Days
