
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
PMA Original Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
P100005 1/23/12 |
M-Vu Algorithm Engine | VuCOMP, Inc. Plano, TX 75093 |
Approval for the M-Vu Algorithm Engine. The device is indicated for use in screening mammography to identify areas consistent with breast cancer for radiologist review after completing an initial read. |
P100039 1/20/12 |
ADVIA Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA Centaur and ADVIA Centaur XP Systems |
Siemens Healthcare Diagnostics Tarrytown, NY 10591 |
Approval for ADVIA Centaur Anti-HBs2 (aHBs2) Assay and ADVIA® Centaur Anti-HBs2 (aHBs2) Quality Control Material for use on the ADVIA Centaur and ADVIA Centaur XP Systems. The device is indicated for: ADVIA Centaur Anti-HBs2 (aHBs2) Assay – The ADVIA Centaur anti-HB2 assay is an in vitro diagnostic immunoassay for the qualitative and quantitative determination of total antibodies to hepatitis B surface antigen in human adult, adolescent, and pediatric serum of plasma (EDTA, lithium-heparinized, or sodium-heparinized) and neonatal samples using the ADVIA Centaur and ADVIA Centaur XP Systems. The assay results may be used as an aid in the determination of susceptibility to hepatitis B virus (HBV) infection in individuals prior to or following HBV vaccination or where vaccination status is unknown. Assay results may be used with other HBV serological markers for the laboratory diagnosis of HBV disease associated with HBV infection. A reactive assay result will allow a differential diagnosis in individuals displaying signs and symptoms of hepatitis in whom etiology is unknown. This assay has not been FDA-cleared or approved for the screening of blood or plasma donors. ADVIA Centaur Anti-HBs2 (aHBs2) Quality Control Material – For in vitro diagnostic use in monitoring the performance of the Anti-HBs2 assay on the ADVIA Centaur Systems. The performance of the Anti-HBs2 quality control material has not been established with any other anti-HBs assays. |
P110016 1/25/12 |
Therapy Cool Path Duo™ Ablation Catheter; Safire BLU Duo™ Ablation Catheter; and IBI 1500T9-CP V1.6 Cardiac Ablation Generator | Irvine Biomedical, Inc. Irvine, CA 92614 |
Approval for the Therapy Cool Path Duo™ Ablation Catheter; Safire BLU Duo™ Ablation Catheter; and IBI 1500T-9 VI.6 Cardiac Ablation Generator. The device is indicated for use with the compatible Irrigation pump and 1500T9-CP Radiofrequency (RF) Generator at a maximum of 50 watts. The catheter is intended for creating endocardial lesions during cardiac ablation procedures (mapping, stimulation and ablation) for the treatment of typical atrial flutter. |
P110031 1/3/12 |
Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer | Roche Diagnostics Indianapols, IN 46250 |
Approval for the Elecsys® Anti-HBc IgM Immunoassay and Elecsys® PreciControl Anti-HBc IgM for use on the cobas e 411 Immunoassay Analyzer. The device is indicated for: Elecsys® Anti-HBc IgM Immunoassay – The Elecsys® Anti-HBc IgM Immunoassay is intended for the in vitro qualitative determination of IgM antibodies to hepatitis B core antigen (anti-HBc IgM) in human serum or plasma (potassium EDTA, lithium heparin, sodium heparin, sodium citrate) in adult patients with symptoms of hepatitis or who may be at risk for hepatitis B (HBV) infection. The presence of anti-HBc IgM, in conjunction with other laboratory results and clinical information, is indicative of acute or recent hepatitis B virus (HBV) infection. The Elecsys® Anti-HBc IgM Immunoassay’s performance has not been established for the monitoring of HBV disease or therapy. The electrochemi- luminescence immunoassay “ECLIA” is intended for use on the cobas e 411 immunoassay analyzer. Elecsys® PreciControl Anti-HBc IgM – The Elecsys® PreciControl Anti-HBc IgM is used for the quality control of the Elecsys® Anti-HBc IgM Immunoassay on the cobas e 411 immunoassay analyzer. |
PMA Supplemental Approvals
APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
---|---|---|---|
N16837/S008 1/10/12 135-Day |
Artegraft Collagen Vascular Graft | Artegraft, Inc. North Brunswick, NJ 08902 |
Approval for the addition of an alternative supplier of a major component for the manufacturing of the device. |
N17600/S026 1/23/12 Special |
Avitene Microfibrillar Collagen Hemostat/ Flour and Avitene Microfibrillar Collagen Hemostat/ Non-Woven Web | Davol, Incorporated Warwick, RI 02886 |
Approval for the addition of a precautions section to the Instructions for Use for the Avitene family of products. The additional language is as follows: "Any excess Avitene MCH not removed at the time of surgery may either present itself as a (recurring) mass or a (space occupying) lesion or it may lead to a foreign body reaction that may present with or without clinical signs and symptoms as a recurring mass or lesion or postoperative abscess formation upon imaging. Imaging may initially not be capable of distinguishing the difference. Removal of excess material, ideally performed upon conclusion of the initial procedure, typically resolves all signs and symptoms." |
P800002/S018 1/23/12 180-Day |
Avitene Microfibrillar Collagen Hemostat/ Flour and Avitene Microfibrillar Collagen Hemostat/ Non-Woven Web | Davol, Incorporated Warwick, RI 02886 |
Approval for the addition of a precautions section to the Instructions for Use for the Avitene family of products. The additional language is as follows: "Any excess Avitene MCH not removed at the time of surgery may either present itself as a (recurring) mass or a (space occupying) lesion or it may lead to a foreign body reaction that may present with or without clinical signs and symptoms as a recurring mass or lesion or postoperative abscess formation upon imaging. Imaging may initially not be capable of distinguishing the difference. Removal of excess material, ideally performed upon conclusion of the initial procedure, typically resolves all signs and symptoms." |
P810025/S029 1/17/12 180-Day |
Amvisc and Amvisc Plus | Anika Therapeutics, Incorporated Bedford, MA 01730 |
Approval for a manufacturing site located at Anika Therapeutics, Inc., in Bedford, Massachusetts. |
P830055/S119 1/6/12 135-Day |
LCS Total Knee System | DePuy Orthopedics, Inc. Warsaw, IN 46581 |
Approval for changes to the final cleaning and passivation processes for the femoral device. |
P860004/S147 1/20/12 180-Day |
Medtronic Catheters | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for a manufacturing site located at Medtronic Puerto Rico Operations Co., in Juncos, Puerto Rico. |
P860004/S151 1/13/12 135-Day |
SynchroMed II Infusion Pump | Medtronic Neuromodulation Minneapolis, MN 55432 |
Approval for a manufacturing change related to the desiccant inspection step for the SynchroMed II Infusion Pump, Model 8637. |
P890003/S179 1/9/12 180-Day |
Medtronic® CareLink Monitor, CardioSight® Reader and DDMA | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the DF4 Connector System, which is comprised of the ICD, CRT-D and defibrillation lead devices for the devices. |
P890055/S035 1/5/12 135-Day |
MedStream Programmable Infusion System | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Approval for an alternate supplier for the passivation of components needed to manufacture accessories used with the Codman 3000 Series Constant Flow Implantable Infusion Pump and MedStream Programmable Infusion Pump. |
P890057/S020 1/31/12 135-Day |
High Frequency Oscillating Ventilator | CareFusion Yorba Linda, CA 92887 |
Approval for the addition of an adhesive to the welded joints of the breathing circuit hub in the device. |
P910001/S047 1/13/12 180-Day |
ECLA Coronary Atherectomy Catheters | Spectranetics Corporation Colorado Springs, CO 80906 |
Approval for a manufacturing site located in Colorado Springs, Colorado. |
P910071/S013 1/24/12 Real-Time |
ADATO® SIL-OL 5000 Silicone Oil | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 |
Approval for the addition of a heat shrink tube to the primary packaging for the device to assure a tighter fit between the luer adapter and the syringe barrel body. |
P910073/S091 1/5/12 180-Day |
ENDOTAK RELIANCE IS-1 Passive Fixation Leads | Boston Scientific CRV St. Paul, MN 55112 |
Approval for drug material and supplier changes as well as distal tip design changes. |
P920015/S055 1/9/12 180-Day |
Medtronic® Sprint Quattro Secure® Defibrillation Lead | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the DF4 Connector System, which is comprised of the ICD, CRT-D and defibrillation lead devices for the devices. |
P940016/S014 1/13/12 180-Day |
H.E.L.P. Plasmat® Futura Apheresis System | B. Braun Medical, Inc. Allentown, PA 18109 |
Approval for a change in the potting resin used to anchor the membranes of the Heparin Adsorber and the Plasmafilter Haemoselect components of the system. |
P940035/S007 1/20/12 180-Day |
Alere™ NMP22® Test Kit, Alere™ NMP22®Urine Collection Kit | Alere Scarborough, Inc. Scarborough, ME 04074 |
Approval for the NMP22® Test Kit and NMP22 Urine Collection Kit under Alere Scarborough, Inc.’s brand name. The devices, as modified, will be marketed under: Trade name Alere™ NMP22® Test with the following Intended Use: Alere™ NMP22® Test is an enzyme immunoassay (EIA) for the in vitro quantitative determination of the nuclear mitotic apparatus protein (NuMA) in stabilized voided urine. The Alere™ NMP22® Test Kit is indicated as an aid 1) in the diagnosis of persons with symptoms or risk factors for transitional cell cancer (TCC) of the bladder (cut-off ≥ 7.5 U/mL) in conjunction with, and not in lieu of, current standard diagnostic procedures, and 2) in management of patients of transitional cell carcinoma of the bladder, after surgical treatment to identify those patients with occult or rapidly recurring TCC (cut-off > 10 U/mL). Trade name Alere™ NMP22® Urine Collection Kit, with the following Intended Use: The Alere™ NMP22® Urine Collection Kit is intended for the collection, stabilization, and transport of human urine which will be tested using the Alere™ NMP22® Test Kit. |
P960042/S029 1/13/12 180-Day |
Spectranetics Laser Sheath (SLS) | Spectranetics Corporation Colorado Springs, CO 80906 |
Approval for a manufacturing site located in Colorado Springs, Colorado. |
P970020/S065 1/6/12 135-Day |
MultiLink Zeta, Pixel and ULTRA Coronary Stent Systems | Abbott Vascular Temecula, CA 92590 |
Approval for a new automated tubing extrusion measurement process. |
P980016/S216 1/9/12 180-Day |
Medtronic® Secura® DR D204DRM and Maximo® II D264DRM Implantable Cardioverter Defibrillators, Model 9995 v7.3 application software | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the DF4 Connector System, which is comprised of the ICD, CRT-D and defibrillation lead devices for the devices. |
P000010/S024 1/11/12 180-Day |
AMPLICOR HCV Test, v2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a change to the test method for determination of Dithiothreitol in bulk and vialed lysis reagents. |
P000012/S033 1/11/12 180-Day |
COBAS AMPLICOR HCV Test, v2.0 and COBAS AmpliPrep/ COBAS AMPLICOR HCV Test, v2.0 | Roche Molecular Systems, Inc. Pleasanton, CA 94588 |
Approval for a change to the test method for determination of Dithiothreitol in bulk and vialed lysis reagents. |
P000013/S010 1/18/12 Real-Time |
Osteonics ABC/Trident Systems | Howmedica Osteonics Corporation Mahwah, NJ 07430 |
Approval for the addition of the Tritanium PSF Acetabular Shells (solid-backed and cluster screw-hole designs) as compatible components with the Trident Ceramic Inserts, as well as modifications to the tolerances and surface roughness values of the taper region of all compatible Trident and Tritanium Acetabular Shells. In addition, labeling changes were made to address the compatibility with the new components. |
P000023/S006 1/31/12 180-Day |
TMJ Fossa-Eminence and Condylar Prosthesis System | TMJ Medical Golden, CO 80401 |
Approval for labeling changes to update the owner and company name, manufacturing suite, standardization of the product names, and adverse events section related to completion of the post-approval study. |
P000035/S006 1/31/12 180-Day |
TMJ Fossa-Eminence Prosthesis System | TMJ Medical Golden, CO 80401 |
Approval for labeling changes to update the owner and company name, manufacturing suite, standardization of the product names, and adverse events section related to completion of the post-approval study. |
P000039/S043 1/10/12 Special |
AMPLATZER® Septal Occluder | AGA Medical Corporation Plymouth, MN 55442 |
Approval for labeling changes regarding device erosion. |
P000040/S020 1/24/12 180-Day |
Genesys HTA™ System | Boston Scientific Corporation Marlborough, MA 01752 |
Approval for software changes to the Genesys HTA System control Unit. |
P000046/S017 1/17/12 180-Day |
Staarvisc II and Shellgell | Anika Therapeutics, Incorporated Bedford, MA 01730 |
Approval for a manufacturing site located at Anika Therapeutics, Inc., in Bedford, Massachusetts. |
P010031/S176 1/9/12 180-Day |
Medtronic® Consulta® CRT-D D204TRM and Maximo® II CRT-D D264TRM Implantable Cardioverter Defibrillators with Cardiac Resynchronization, Model 9995 v7.3 application software | Medtronic, Inc. Mounds View, MN 55112 |
Approval for the DF4 Connector System, which is comprised of the ICD, CRT-D and defibrillation lead devices for the devices. |
P020002/S006 1/23/12 Real-Time |
Review Scope Manual+ | Hologic, Inc. Marlborough, MA 01752 |
Approval for the Review Scope Manual+. |
P020026/S082 1/27/12 180-Day |
CYPHER® Sirolimus-Eluting Coronary Stent on SONIX™ Rapid Exchange Delivery System | Cordis Corporation Miami Lakes, FL 33014 |
Approval for the SONIX™ Rapid Exchange Delivery System for the CYPHER Sirolimus-eluting Coronary Stent. |
P020026/S085 1/26/12 180-Day |
CYPHER® Sirolimus-Eluting Coronary Stent on SONIX™ RX Delivery System | Cordis Corporation Miami Lakes, FL 33014 |
Approval to integrate the XTEND manufacturing process into the CYPHER Stent mounted on the SONIX RX delivery system. |
P020047/S036 1/6/12 135-Day |
Vision, MiniVision and ML8 Coronary Stent Systems | Abbott Vascular Temecula, CA 92590 |
Approval for a new automated tubing extrusion measurement process. |
P030031/S033 1/13/12 135-Day |
NAVISTAR RMT ThermoCool Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a second source supplier of a catheter component. |
P040012/S039 1/6/12 135-Day |
Acculink Cartoid Stent System | Abbott Vascular Temecula, CA 92590 |
Approval for a new automated tubing extrusion measurement process. |
P040024/S053 1/26/12 180-Day |
Restylane Injectable Gel | Medicis Pharmaceutical Corporation Scottsdale, AZ 85256 |
Approval for a relocation of the current Quality Control laboratory (QC-lab) for chemical, microbiological and receiving inspection analysis to a new location with Q-Med’s existing facilities. |
P040036/S024 1/13/12 135-Day |
NAVISTAR RMT ThermoCool Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for a second source supplier of a catheter component. |
P040043/S040 1/13/12 180-Day |
GORE TAG Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 |
Approval for the GORE TAG Thoracic Endoprosthesis. The device is intended for endovascular repair of isolated lesions (not including dissections) of the descending thoracic aorta, in patients who have appropriate anatomy including adequate iliac/femoral access, aortic inner diameter in the range of 16-42 mm, and ≥ 20 mm non-aneurysmal aorta proximal and distal to the lesion. |
P040044/S040 1/13/12 Real-Time |
MynxGrip™ Vascular Closure Device | Access Closure Mountain View, CA 94043 |
Approval for integrating the catheter delivery system of the Mynx Cadence device with the hydrogel sealant of the Mynx with Grip Technology device. The device, as modified, will be marketed under the trade name MynxGrip ™ Vascular Closure Device and is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 6F or 7F procedural sheath. |
P050019/S008 1/27/12 180-Day |
Carotid WALLSTENT Monorail Endoprosthesis | Boston Scientific Corporation Maple Grove, MN 55311 |
Approval for modifications to the labeling to include the post-approval study findings. |
P050044/S019 1/31/12 180-Day |
Vitagel™ Surgical Hemostat | Stryker Corporation Malvern, PA 19355 |
Approval for a design change (removal of the metering knob) to the CellPaker component of the Vitagel Surgical Hemostat system, introduction of a new contract manufacturer located at Tegra Medical in Darthmouth, Massachusetts, a change to the packaging materials and sterilization methods for the system component, and the re-branding of the CellPaker component as VitaPrep Plasma Separator. |
P050047/S018 1/20/12 135-Day |
Juvederm Hyaluronate Gel Implants | Allergan Goleta, CA 93117 |
Approval to add additional testing on two raw materials used in the manufacture of the device which included additional testing of raw materials. |
P050047/S020 1/20/12 Real-Time |
Juvederm Ultra XC and Juvederm Ultra Plus XC |
Allergan Goleta, CA 93117 |
Approval for an extension of the shelf life from 12 months to 18 months for the 1.0mL syringe; an increase in the monoethylglycin-exylidide (MEGX) impurity specification from ≤0.3% w/w of label strength to ≤2.5% w/w of label strength; and an increase in individual unidentified impurities specifications from ≤0.1% w/w of label strength to ≤0.2% w/w of label strength. |
P070006/S006 1/4/12 180-Day |
T-SPOT.TB Test | Oxford Immunotec, Ltd. Toms River, NJ 08754 |
Approval for the use of T-Cell Xtend reagent in extending whole blood storage from 0-32 hours prior to assaying with the T-SPOT.TB test. |
P070015/S075 1/6/12 135-Day |
XIENCE V and XIENCE nano Everolimus Eluting Coronary Stent Systems (EECSS) | Abbott Vascular Temecula, CA 92590 |
Approval for a new automated tubing extrusion measurement process. |
P100021/S012 1/6/12 180-Day |
Endurant Stent Graft System | Medtronic Vascular Santa Rosa, CA 95403 |
Approval of the post-approval study protocol. |
P100034/S001 1/3/12 180-Day |
NovoTTF-100A Treatment Kit | NovoCure, Ltd. Rye Beach, NH 03871 |
Approval of the post-approval study protocol. |
P110019/S002 1/4/12 Real-Time |
XIENCE PRIME and XIENCE PRIME LL Everolimus Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92590 |
Approval to update the labeling for the XIENCE PRIME Everolimus Eluting Coronary Stent System to reflect an 180 month shelf life. |
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/S048 1/20/12 |
EBI Osteogen Implantable Bone Growth Stimulator | Biomet Spine & Bone Healing Technologies d.b.a. EBI, LLC Parsippany, NJ 07054 |
Addition of new in-process package seal strength tests. |
P840001/S201 1/12/12 |
RestoreSensor Implantable Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Three software changes, automation of the Bond Pad Array manufacturing process, and minor changes to the ethylene oxide residual testing procedures. |
P840001/S202 1/13/12 |
Spinal Cord Stimulation (SCS) Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of two new desktop welding stations with updated power supplies, and two process changes to include the consolidation of production laser weld program code and reducing frequency parameters for the welding process. |
P840001/S203 1/20/12 |
Itrel 3 Implantable Neurostimulator, Synergy Family of Implantable Neurostimulators and Restore Family of Implantable Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Thermal processing of Eccobond epoxy resin E3450(A) prior to consumption in routine manufacturing. |
P840064/S047 1/20/12 |
PROVISC, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Devices | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Changes to the syringe component sterilization processes. |
P860003/S063 1/10/12 |
THERAKOS CELLEX Photopheresis Procedure Kit | THERAKOS, Inc. Raritan, NJ 08869 |
Change in the tube cutting process. |
P860057/S082 1/19/12 |
Carpentier-Edwards PERIMOUNT Pericardial Bioprostheses | Edwards Lifesciences, Inc. Irvine, CA 92614 |
Addition of Hawkins Inc., as an alternate supplier of sodium chloride. |
P860057/S083 1/18/12 |
Carpentier-Edwards PERIMOUNT Bioprosthetic Valve | Edwards Lifesciences, Inc. Irvine, CA 92614 |
Additional supplier of bovine tissue. |
P870056/S045 1/19/12 |
Carpentier-Edwards Bioprostheses and Valved Conduit | Edwards Lifesciences, Inc. Irvine, CA 92614 |
Addition of Hawkins Inc., as an alternate supplier of sodium chloride. |
P870077/S041 1/19/12 |
Carpentier-Edwards Duraflex Low Pressure Mitral Bioprosthesis | Edwards Lifesciences, Inc. Irvine, CA 92614 |
Addition of Hawkins Inc., as an alternate supplier of sodium chloride. |
P890003/S243 1/18/12 |
Prodigy IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of thermal processing for a manufacturing component used during routine manufacturing. |
P890047/S035 1/20/12 |
PROVISC, DUOVISC and DISCOVISC Ophthalmic Viscosurgical Devices | Alcon Laboratories, Inc. Fort Worth, TX 76134 |
Changes to the syringe component sterilization processes. |
P890055/S038 1/17/12 |
Codman 3000 Series Constant Flow Implantable Infusion Pump and Accessories | Codman & Shurtleff, Inc. Raynham, MA 02767 |
Manufacturing process change to the device used with the Codman 3000 Series Constant Flow Implantable Infusion Pump and MedStream Programmable Infusion Pump. |
P900066/S011 1/5/12 |
ISPAN Perfluoropropane C3F8 Gas | Air Liquide Healthcare America Corporation Plumsteadville, PA 18949 |
Replacement of the ion chromatograph. |
P900067/S007 1/20/12 |
IPSAN Sulfur Hexafluoride SF6 Gas | Air Liquide Healthcare America Corporation Plumsteadville, PA 18949 |
Replace the ion chromatograph for Quality Control product testing. |
P940015/S024 1/5/12 |
Synvisc® and Synvisc-One® | Genzyme Corporation Cambridge, MA 02142 |
Addition of a larger filling vessel. |
P960009/S135 1/13/12 |
Deep Brain Stimulation (DBS) Leads |
Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of two new desktop welding stations with updated power supplies, and two process changes to include the consolidation of production laser weld program code and reducing frequency parameters for the welding process. |
P960009/S136 1/20/12 |
Soletra Neurostimulator, Kinetra Neurostimulator and Activa Family of Neurostimulators | Medtronic Neuromodulation Minneapolis, MN 55432 |
Thermal processing of Eccobond epoxy resin E3450(A) prior to consumption in routine manufacturing. |
P960011/S020 1/27/12 |
BVI 1% OVD (1% Sodium Hyaluronate Viscoelastic Surgical Aid Fluid) | Ferring Pharmaceuticals Incorporated Parsippany, NJ 07054 |
New viscometer for the in-process and Quality Control release testing. |
P960040/S247 1/13/12 |
Teligen, Incepta, Energen, Punctua ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Use of a new cathode material in the high voltage capacitor and a new supplier. |
P960040/S248 1/19/12 |
Teligen, Incepta, Energen, Punctua CRT-Ds | Boston Scientific CRM St. Paul, MN 55112 |
Addition of a new supplier for a resistor component. |
P960040/S249 1/25/12 |
Teligen, Incepta, Energen, Punctua ICDs | Boston Scientific Corporation St. Paul, MN 55112 |
Manufacture of the battery component to be manufactured internally at its Boston Scientific St. Paul manufacturing facility. |
P960040/S250 1/26/12 |
TELIGEN, INCEPTA, ENERGEN, PUNCTUA and CONFIENT Implantable Cardioverter Defibrillators | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a new supplier for the antenna sock component, and for changes to the receiving acceptance activities. |
P970003/S143 1/18/12 |
VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 |
Changes to the parallel gap welding step during the manufacturing of the leads for the device. |
P970004/S127 1/13/12 |
InterStim Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of two new desktop welding stations with updated power supplies, and two process changes to include the consolidation of production laser weld program code and reducing frequency parameters for the welding process. |
P970004/S128 1/20/12 |
InterStim Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Thermal processing of Eccobond epoxy resin E3450(A) prior to consumption in routine manufacturing. |
P970012/S129 1/31/12 |
Interstim Sacral Nerve Stimulation Therapy System, Test Stimulation Lead and Stimulation Lead Kit | Medtronic Neuromodulation Minneapolis, MN 55432 |
Alternate supplier for a process for coating conductor wire. |
P970012/S090 1/18/12 |
Kappa 400 DR/SR IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of thermal processing for a manufacturing component used during routine manufacturing. |
P980016/S333 1/18/12 |
Marquis, Maximo, Intrinsic, EnTrust, Virtuoso, Maximo II, Virtuoso II, Secura, Protecta XT, Protecta, and ProtectaXT/Protecta DF4 ICDs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of thermal processing for a manufacturing component used during routine manufacturing. |
P980035/S255 1/18/12 |
Kappa 700/800/900, Sigma, Medtronic 350, EnPulse, EnRhythm, AT500, Adapta/Versa/ Sensia, Relia and Advisa DR IPGs |
Medtronic, Inc. Mounds View, MN 55112 |
Implementation of thermal processing for a manufacturing component used during routine manufacturing. |
P980049/S068 1/11/12 |
Paradym VR and Paradym DR ICDs | Sorin CRM USA, Inc. Plymouth, MN 55441 |
In-sourcing of an electronic assembly. |
P990001/S099 1/18/12 |
Dema, C-Series and T-Series IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of thermal processing for a manufacturing component used during routine manufacturing. |
P000007/S028 1/19/12 |
Edwards Prima Plus Stentless Biprosthesis | Edwards Lifesciences, Inc. Irvine, CA 92614 |
Addition of Hawkins Inc., as an alternate supplier of sodium chloride. |
P010012/S275 1/13/12 |
Cognis, Incepta, Energen, Punctua CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Use of a new cathode material in the high voltage capacitor and a new supplier. |
P010012/S276 1/19/12 |
Cognis, Incepta, Energen, Punctua CRT-Ds | Boston Scientific CRM St. Paul, MN 55112 |
Addition of a new supplier for a resistor component. |
P010012/S277 1/25/12 |
Cognis, Incepta, Energen, Punctua CRT-Ds | Boston Scientific Corporation St. Paul, MN 55112 |
Manufacture of the battery component to be manufactured internally at its Boston Scientific St. Paul manufacturing facility. |
P010012/S278 1/26/12 |
COGNIS, INCEPTA, ENGERGEN, PUNCTUA, LIVIAN Cardiac Resynchronization Therapy-Defibrillators | Boston Scientific Corporation St. Paul, MN 55112 |
Addition of a new supplier for the antenna sock component, and for changes to the receiving acceptance activities. |
P010015/S151 1/18/12 |
InSync, InSync III, Consulta and Syncra CRT-Ps | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of thermal processing for a manufacturing component used during routine manufacturing. |
P010019/S027 1/10/12 |
Lotrafilcon B Soft Contact Lenses for Extended Wear | CIBA VISION Corporation Duluth, GA 30097 |
Automation of the Tray Transfer System. |
P010029/S013 1/27/12 |
EUFLEXXA (1% Sodium Hyaluronate) |
Ferring Pharmaceuticals Incorporated Parsippany, NJ 07054 |
New viscometer for the in-process and Quality Control release testing. |
P010031/S286 1/18/12 |
InSync Marquis, InSync II Marquis, InSync III Marquis, InSync Sentry, and Insync Maximo ICDs and Concerto, Concerto II, Maximo II, Consulta, Protecta XT, Protecta and Protecta DF4 CRT-Ds |
Medtronic, Inc. Mounds View, MN 55112 |
Implementation of thermal processing for a manufacturing component used during routine manufacturing. |
P010032/S044 1/6/12 |
The EonMini IPG | St. Jude Medical Plano, TX 75024 |
Add a backside lamination to components installed on the printed circuit board (PCB). |
P010032/S045 1/19/12 |
Genesis, Eon, EonC Eon Mini Neurostimulation Systems | St. Jude Medical Piano, TX 75024 |
Manufacturing process change to add an in-process inspection step for the devices. |
P010041/S029 1/19/12 |
Carpentier-Edwards Supraannular (S.A.V.) Bioprosthesis | Edward Lifesciences, Inc. Irvine, CA 92614 |
Addition of Hawkins Inc., as an alternate supplier of sodium chloride. |
P020004/S068 1/13/12 |
EXCLUDER AAA Endo Catheter | W.L. Gore & Associates, Inc. Flagstaff, AZ 86003 |
Use of additional manufacturing equipment for laser cutting. |
P020045/S041 1/13/12 |
Freezor® Cardiac CryoAblation Catheter, Freezor® Xtra Surgical Cardiac CryoAblation Device and Freezor® MAX Surgical Cardiac CryoAblation Device | Medtronic CryoCath, LP Pointe Claire, Quebec, Canada H9R 5Z8 |
Streamlining the inspection procedure for the Freezor® family of catheters. |
P030017/S125 1/4/12 |
Precision Spinal Cord Stimulator (SCS) System | Boston Scientific Neuromodulation Valencia, CA 91355 |
A new fabrication site for the supplier of the Analog Integrated Circuit (IC) in the Printed Circuit Board Assembly (PCBA) of the Implantable Pulse Generator (IPG) for the Precision Spinal Cord Stimulator (SCS) System. |
P030022/S020 1/20/12 |
Reflection Ceramic Hip System | Smith & Nephew, Inc. Memphis, TN 38116 |
Change in the hip stem coating process. |
P040044/S042 1/6/12 |
Mynx Vascular Closure Device Product Family | Access Closure, Inc. Mountain View, CA 94043 |
Change to the freeze-dry process and equipment. |
P050012/S043 1/18/12 |
Dexcom™ SEVEN® and SEVEN PLUS® Continuous Glucose Monitoring Systems | Dexcom, Inc. San Diego, CA 92121 |
Change in a manufacturing fixture used in the attachment of an adhesive patch in the Sensor/ Applicator Delivery System component in the SEVEN® and SEVEN PLUS® Continuous Glucose Monitoring Systems. Additionally, the mechanical instron pull test was replaced with a manual adhesive patch pull test to be used in Receiving inspection for the disposable housing of the SEVEN® and SEVEN PLUS® Continuous Glucose Monitoring Systems. |
P060001/S016 1/18/12 |
Protègè GPS and Protègè RX Carotid Stent Systems | Ev3, Inc. Plymouth, MN 55441 |
Addition of a 7-pallet sterilizer vessel at the contract sterilizer. |
P060002/S023 1/18/12 |
Bard FLAIR Endovascular Stent Graft | Bard Peripheral Vascular, Incorporated Tempe, AZ 85281 |
Use of an alternate ink on the delivery system handle. |
P060007/S017 1/13/12 |
ARCHITECT HBsAg and HBsAg Confirmatory | Abbott Laboratories Abbott Park, IL 60064 |
Change to a quality control test method used for bioburden evaluation. |
P060027/S035 1/11/12 |
Paradym CRT-D | Sorin CRM USA, Inc. Plymouth, MN 55441 |
In-sourcing of an electronic assembly. |
P070015/S085 1/20/12 |
XIENCE V Everolimus-Eluting Coronary Stent System and XIENCE nano Everolimus-Eluting Coronary Stent System/PROMUS Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Addition of an alternate manufacturing site for drug sublotting and the implementation of a new piece of equipment for pouch sealing. |
P080004/S010 1/20/12 |
Hoya iSpheric | Hoya Surgical Optics, Inc. Chino Hills, CA 91709 |
Change to the incubation time of the Biological Indicator. |
P080014/S010 1/20/12 |
Cervista® Human Papilloma Virus (HPV) High Risk (HR) | Hologic, LP Marlborough, MA 01752 |
Change to replace quality control test method controls with new quality control test method controls from the same supplier for incoming materials inspection testing and in-process quality control testing of accessory kit reagents. |
P080025/S024 1/13/12 |
InterStim Leads | Medtronic Neuromodulation Minneapolis, MN 55432 |
Addition of two new desktop welding stations with updated power supplies, and two process changes to include the consolidation of production laser weld program code and reducing frequency parameters for the welding process. |
P080025/S025 1/20/12 |
InterStim II Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 |
Thermal processing of Eccobond epoxy resin E3450(A) prior to consumption in routine manufacturing. |
P080025/S026 1/30/12 |
Interstim Sacral Nerve Stimulation Therapy System, Test Stimulation Lead and Test Stimulation Lead Kit | Medtronic Neuromodulation Minneapolis, MN 55432 |
Alternate supplier for a process for coating conductor wire. |
P090013/S049 1/18/12 |
Revo MRI IPGs | Medtronic, Inc. Mounds View, MN 55112 |
Implementation of thermal processing for a manufacturing component used during routine manufacturing. |
P100010/S013 1/13/12 |
Freezor® MAX Cardiac CryoAblation Catheter | Medtronic CryoCath LP Pointe Claire, Quebec, Canada H9R SZ8 |
Streamlining the inspection procedure for the Freezor® family of catheters. |
P100023/S031 1/20/12 |
ION (TAXUS Element) Paclitaxel- Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Addition of an alternative combination mandrel for welding during assembly. |
P100023/S032 1/25/12 |
ION Paclitaxel-Eluting Platinum Chromium Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Use of a new statistical analysis software package in the manufacturing process. |
P100041/S003 1/19/12 |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, Inc. Irvine, CA 92614 |
Addition of Hawkins Inc., as an alternate supplier of sodium chloride. |
P100041/S004 1/18/12 |
Edwards SAPIEN Transcatheter Heart Valve | Edwards Lifesciences, Inc. Irvine, CA 92614 |
Additional supplier of bovine tissue. |
P110010/S003 1/13/12 |
PROMUS Element Plus Platinum Chromium Everolimus-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 |
Software and equipment hardware updates to a sterilization chamber at the Coventry, Rhode Island facility. |
P110019/S006 1/18/12 |
XIENCE PRIME EECSS and XIENCE PRIME LL ECSS | Abbot Vascular Temecula, CA 92591 |
Remove redundant cleaning and treatment steps and include cleanroom process modifications. |
P110019/S007 1/18/12 |
XIENCE PRIME and XIENCE PRIME LL Everolimus-Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 |
Manufacturing change to automate the adaption cup preparation process. |
P110019/S008 1/20/12 |
XIENCE PRIME Everolimus-Eluting Coronary Stent System and XIENCE PRIME LL Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 |
Addition of an alternate manufacturing site for drug sublotting and the implementation of a new piece of equipment for pouch sealing. |
Summary of PMA Originals & Supplements Approved
Originals: 4
Supplements: 47
Summary of PMA Originals Under Review
Total Under Review: 79
Total Active: 33
Total On Hold: 46
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 560
Total Active: 413
Total On Hold: 147
Number Greater Than 180 Days: 8
Summary of All PMA Submissions Received
Originals: 1
Supplements: 71
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 47
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 248.7
FDA Time: 162.0 Days MFR Time: 86.7 Days