Medical Devices
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May 2010 PMA Approvals
Below are Premarket Approvals (PMA), Product Development Protocols (PDP), Supplement and Notice Decisions. This list is generated on a monthly basis.
A PDF document that contains the "Approval letter and Summary of Safety and Effectiveness" is being added to this listing for each PMA. The PMA number will appear as a link if this document is available.
PMA Original Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P050027 5/28/10 | Karl Storz Photodynamic Diagnostic D-Light C (PDD) System | Karl Storz Endoscopy-America, Inc. El Segundo, CA 90245 | Approval for the Karl Storz Photodynamic Diagnostic D-Light C (PDD) System. The Karl Storz Photodynamic Diagnostic D-Light C (PDD) System in combination with the optical imaging drug Cysview® (hexaminolevulinate hydrochloride) for Intravesical Solution is indicated for photodynamic blue light cystoscopy, as an adjunct to white light cystoscopy for the detection of non-muscle invasive papillary cancer of the bladder in patients suspected or known to have the lesion on the basis of a prior cystoscopy. |
PMA Supplemental Approvals
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
|---|---|---|---|
| P810031/S037 5/20/10 Real-Time | Sodium Hyaluronate Ophthalmic Viscoelastic Devices (OVD), Healon®, Healon GV® and Healon5® | Abbott Medical Optics, Inc. Santa Ana, CA 92705 | Approval for a change in packaging for two individual blister tray packs (Healon® & Healon5®) to be packed in a single carton box. |
| P820003/S093 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P850051/S072 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P850079/S047 5/3/10 180-Day | CLEAR SOFT (methafilcon A) Soft (Hydrophilic) Contact Lenses for Extended Wear | CooperVision Norfolk, VA 23507 | Approval for the trade name CLEAR SOFT. The device, as modified, will be marketed under the trade name CLEAR SOFT and is indicated for: CLEAR SOFT Sphere (methafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters. The lenses may be worn by persons who exhibit astigmatism of -2.00 diopters or less that does not interfere with visual acuity. CLEAR SOFT Toric (methafilcon A) Soft Contact lenses are indicated for the correction of ametropia (myopia or hyperopia with astigmatism) in aphakic and non-aphakic persons with non-diseased eyes in powers from -20.00 to +20.00 diopters and astigmatic corrections from -0.25 to -5.00 diopters. The CLEAR SOFT (methafilcon A) Soft (Hydrophilic) Contact Lenses have been approved for extended wear for up to 6 nights/7 days of continuous wear. It is recommended that the contact lens wearer first be evaluated on a daily wear schedule. If successful, then a gradual introduction of extended wear can be followed as determined by the prescribing Eye Care Practitioner. Eye care practitioners may prescribe the lens for frequent replacement wear with cleaning, disinfecting and scheduled replacements. |
| P860019/S252 5/11/10 Real-Time | Quantum Maverick OTW, Apex OTW, Maverick OTW, and Maverick XL Monorail PTCA Dilatation Catheters | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for material and specification changes to the strain relief. |
| P890003/S186 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P890003/S188 5/11/10 Real-Time | Medtronic® CareLink Device Data Management Application (DDMA) Model 2491 | Medtronic, Inc. Mounds View, MN 55112 | Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events. |
| P900061/S087 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P910023/S226 5/7/10 180-Day | Fortify VR/DR | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the Fortify VR/DR pulse generators. |
| P910077/S104 5/19/10 Real-Time | Zoom Latitude Programmer | Boston Scientific CRM St. Paul, MN 55112 | Approval for a minor design change to the Model 3120 Zoom Latitude programmer and an alternate supplier for the hard drive component in the programmer. |
| P930022/S011 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P950037/S072 5/7/10 180-Day | Evia/Entovis Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the Evia/Entovis Pulse Generators. |
| P960013/S058 5/19/10 Real-Time | OptiSense | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 | Approval for new stylets to be included in the OptiSense Model 1999 lead package. |
| P970003/S109 5/18/10 Special | VNS Therapy System | Cyberonics, Inc. Houston, TX 77058 | Approval for a labeling modification regarding the internal clock reset in the Model 100, 101, 102 and 102R Implanted pulse Generators (IPGs). |
| P970008/S049 5/13/10 Real-Time | Urologix Targis® System | Urologix, Inc. Minneapolis, MN 55447 | Approval to replace an obsolete touchscreen and modify the microwave generator to improve design margins. |
| P970012/S065 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P970021/S028 5/13/10 180-Day | Gynecare Thermachoice III Uterine Balloon Therapy System | Ethicon, Inc. Somerville, NJ 08876 | Approval for updated professional labeling to reflect the results of the Post-Approval Study required as a condition of approval to Supplement 14. |
| P970051/S057 5/14/10 135-Day | Nucleus 24 Cochlear Implant System | Cochlear Americas Centennial, CO 80111 | Approval for a change to the material used in the manufacturing of the microphone protector cover for the CP810 Sound Processor. |
| P980016/S232 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P980016/S234 5/11/10 Real-Time | Medtronic® Secura® DR/VR D224DRG/ D224VRC, Maximo® DR/VR D284DRG/ D284VRC, Virtuoso II DR/VR D274DRG/ D274VRC Implantable Cardioverter Defibrillators | Medtronic, Inc. Mounds View, MN 55112 | Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events. |
| P980035/S161 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P980050/S047 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P990001/S064 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P990020/S039 5/21/10 180-Day | ANEURx AAAdvantage Stent Graft Delivery System | Medtronic Vascular Santa Rosa, CA 95403 | Approval for a sterilization site located at Isotron Ireland, LTD., in Offaly, Ireland. |
| P990027/S010 5/18/10 180-Day | Bausch & Lomb Technolas T217z Zyoptix Laser System | Biomed Research, Inc. Lutz, FL 33558 | Approval for the following changes: 1) Removal of a redundant fluence test; 2) Introduction of a new scanner system from GSI to the laser System: 3) Extrapolation of the Wavefront data in the Diagnostic Zywave Software; 4) New ZRS (Zyoptix Remote Support) Software to monitor the performance of the laser and diagnostic devices remotely via the internet; 5) Modification of the ZRS to include TruLink, an enhancement to the ZRS system; 6) Introduction of a new OP field illumination in the laser system; 7) Change of the video chip in the CCD Lenslet Camera DMK4002-IR; and 8) Change in the supplier of the temperature control unit in the laser system. |
| P990038/S013 5/21/10 135-Day | ETI-MAK-2 PLUS & ETI-MAK-2 PLUS HBsAg Confirmatory Test | DiaSorin, Inc. Stillwater, MN 55082 | Approval for changing BSA raw material. |
| P990041/S012 5/21/10 135-Day | ETI-AB-EBK PLUS | DiaSorin, Inc. Stillwater, MN 55082 | Approval for changing BSA raw material. |
| P990042/S009 5/21/10 135-Day | ETI-AB-AUK PLUS | DiaSorin, Inc. Stillwater, MN 55082 | Approval for changing BSA raw material. |
| P990043/S013 5/21/10 135-Day | ETI-EBK PLUS | DiaSorin, Inc. Stillwater, MN 55082 | Approval for changing BSA raw material. |
| P990044/S010 5/21/10 135-Day | ETI-CORE-IGMK PLUS | DiaSorin, Inc. Stillwater, MN 55082 | Approval for changing BSA raw material. |
| P990045/S010 5/21/10 135-Day | ETI-AB-COREK PLUS | DiaSorin, Inc. Stillwater, MN 55082 | Approval for changing BSA raw material. |
| P990066/S035 5/20/10 180-Day | GE-Healthcare Senographe Essential Digital Mammography System | GE Healthcare Milwaukee, WI 53201 | Approval for a modification to the amorphous silicon array design used in the detector of the Senographe Essential full field digital mammography system. The proposed modifications include the following: 1) Reducing the number of layers in the detector amorphous silicon array; 2) Change in the detector firmware to allow the detector configuration to be communicated to the system Image Detector Controller (IDC); 3) IDC software to automatically determine if a detector with the proposed modification is installed on the system and properly select the proper configuration table; and 4) Corresponding changes in the incoming acceptance criteria testing station for the modified detector. |
| P000009/S035 5/7/10 180-Day | Evia/Entovis Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the Evia/Entovis Pulse Generators. |
| P000021/S013 5/19/10 180-Day | Dimension Vista® TPSA Flex® Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. Newark, DE 19714 | Approval for the following changes: 1) Detection technology from spectrophotometry to chemiluminesence; 2) Appropriate reagent process changes to accommodate chemiluminesence detection; 3) Usage on the Dimension Vista® 1500 System; 4) Usage on the Dimension Vista® 3000T System which consists of two Dimension Vista® 1500 Systems connected by a sample track transport mechanism; 5) Usage on the Dimension Vista® 1500 System connected to the StreamLab® analytical Workcell Laboratory Automation System; and 6) The new Dimension Vista® PSA Calibrator for use with the Dimension Vista® TPSA and FPSA methods. The device, as modified, will be marketed under the trade name Dimension Vista® TPSA Flex reagent cartridge and is indicated for the following uses: The TPSA method is an in vitro diagnostic test for the quantitative measurement of total prostate specific antigen (PSA) in human serum and plasma on the Dimension Vista® System: 1) As an aid in the detection of prostate cancer when used in conjunction with digital rectal exam (DRE) in men 50 years or older. Prostate biopsy is required for diagnosis of cancer. 2) As an aid in the management (monitoring) of prostate cancer patients. The Dimension Vista PSA calibrator will be marketed separately for use with the Dimension Vista TPSA Flex reagent and is indicated for the calibration of Total (TPSA) and Free (FPSA) Prostate Specific Antigen methods on the Dimension Vista® Systems. |
| P000021/S015 5/27/10 180-Day | Dimension TPSA Flex Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. Newark, DE 19714 | Approval for the Dimension TPSA Flex reagent cartridge on the Dimension EXL with LM System. |
| P000054/S024 5/17/10 Special | INFUSE® Bone Graft | Medtronic Sofamor Danek Memphis, TN 38132 | Approval for changes to the patient information brochure. |
| P000058/S036 5/17/10 Special | INFUSE® Bone Graft/LT-Cage Lumbar Tapered Fusion Device | Medtronic Sofamor Danek Memphis, TN 38132 | Approval for changes to the patient information brochure. |
| P010003/S015 5/12/10 Special | BioBlue® Surgical Adhesive | CryoLife, Inc. Kennesaw, GA 30144 | Approval for clarification regarding one of the warnings in the Instructions for Use (IFU). |
| P010015/S082 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P010030/S019 5/21/10 Real-Time | LifeVest Wearable Defibrillator WCD 4000 | Zoll Lifecor Corporation Pittsburgh, PA 15238 | Approval for a component value change to the ECG electrode buffer boards to improve ECG amplifier common mode rejection. |
| P010031/S191 5/11/10 Real-Time | Various Device Families | Medtronic, Inc. Mounds View, MN 55112 | Approval for enhancements to the Model 9986 Software. The Model 9986 Software is the Desktop/Baseline Operating System Software (BOSS) for the Medtronic Model 2090 CareLink Programmer. |
| P010031/S193 5/11/10 Real-Time | Medtronic® Consulta CRT-D D224TRK, Maximo® II CRT-D D284TRK, Concerto™ II D274TRK Implantable Cardioverter Defibrillators with Cardiac Resynchronization | Medtronic, Inc. Mounds View, MN 55112 | Approval for updates made to the Programmer Application Software Model 9995 and the CareLink Device Data Management Application (DDMA) in response to adverse field events. |
| P020004/S049 5/5/10 135-Day | GORE EXCLUDER® AAA Endoprosthesis | W.L. Gore and Associates Flagstaff, AZ 86001 | Approval for an expansion of the manufacturing environment. |
| P020004/S050 5/12/10 Real-Time | GORE EXCLUDER® AAA Endoprosthesis | W.L. Gore and Associates Flagstaff, AZ 86001 | Approval for the removal of the center knot sleeve attachment. |
| P020009/S061 5/11/10 Real-Time | Express OTW Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for material and specification changes to the strain relief. |
| P020027/S009 5/17/10 180-Day | Dimension Vista® FPSA Flex® Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. Newark, DE 19714 | Approval for the following changes: 1) Detection technology from spectrophotometry to chemiluminesence; 2) Appropriate reagent process changes to accommodate chemiluminesence detection; 3) Usage on the Dimension Vista® 1500 System; 4) Usage on the Dimension Vista® 3000T System which consists of two Dimension Vista® 1500 Systems connected by a sample track transport mechanism; and 5) Usage on the Dimension Vista® 1500 System connected to the StreamLab® analytical Workcell Laboratory Automation System. The device, as modified, will be marketed under the trade name Dimension Vista® FPSA Flex reagent cartridge and is indicated for: The FPSA method for the Dimension Vista® System is an in vitro diagnostic test intended to quantitatively measure free prostate specific antigen (FPSA) in human serum and plasma. Measurements of FPSA are used in conjunction with total PSA (TPSA) method on Dimension Vista® System to calculate FPSA to TPSA ratio expressed as a percent FPSA. The percent FPSA is used as an aid in distinguishing prostate cancer from benign prostate conditions in men 50 years or older with TPSA of 4.0 to 1.0 ng/mL and DRE findings not suspicious for cancer. Prostate biopsy is required for diagnosis of cancer. |
| P020027/S010 5/27/10 180-Day | Dimension FPSA Flex Reagent Cartridge | Siemens Healthcare Diagnostics, Inc. Newark, DE 19714 | Approval for the Dimension FPSA Flex reagent cartridge on the Dimension EXL with LM System. |
| P030017/S098 5/6/10 Real-Time | Precision® Spinal Cord Stimulation (SCS) System | Boston Scientific Neuromodulation Corp. Valencia, CA 91355 | Approval for a consolidation of three separate instruction manuals (i.e., Physician Implant, Physician Lead, and Physician Surgical Lead Manuals) into a single manual, the Physician System Clinical manual. |
| P030025/S085 5/11/10 Real-Time | Taxus Express2 Coronary Stent System, Taxus Express2 Atom Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for material and specification changes to the strain relief. |
| P030054/S130 5/10/10 180-Day | QuickFlex µ Left Ventricular Lead | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 | Approval for the QuickFlex µ Model 1258TLeft Ventricular Lead. |
| P030054/S141 5/7/10 180-Day | Unify CRT-D | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for the Unify CRT-D pulse generators. |
| P030054/S146 5/3/10 180-Day | Merlin Patient Care System Programmer Model 3650 | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 | Approval for: 1) The addition of the pacing systems analyzer (PSA) model EX3100. The model EX3100 also includes accessories: a) Merlin Antenna Adapter EX3190; b) Merlin Cable Adapter EX3170; and c) Merlin “M” Adapter EX3180; and 2) The addition of the Model 3330 version 10.1.1 software. |
| P040002/S027 5/12/10 Real-Time | PowerLink System | Endologix, Inc. Irvine, CA 92618 | Approval for new PowerLink system models, including bifurcated devices with new lengths and diameters, limb extensions with new lengths, and aortic extensions with new lengths. |
| P040016/S054 5/11/10 Real-Time | VeriFLEX OTW Bare-Metal Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for material and specification changes to the strain relief. |
| P040034/S016 5/28/10 180-Day | DuraSeal® Dural Sealant System | Confluent Surgical, Inc. Bedford, MA 01730 | Approval to update the contents of the DuraSeal Package Insert based on the results of the post-approval study. |
| P040043/S033 5/25/10 Real-Time | GORE TAG Thoracic Endoprosthesis | W.L. Gore & Associates, Inc. Flagstaff, AZ 86001 | Approval for a new 22 mm constraining sleeve size to be used in the 40 mm diameter TAG device. |
| P050023/S024 5/7/10 180-Day | Evia/Entovis Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the Evia/Entovis Pulse Generators. |
| P050033/S008 5/24/10 Special | Elevess | Anika Therapeutics, Inc. Bedford, MA 01730 | Approval for revision of the physician and patient labels to include updates on the post market adverse event experience with the device. |
| P060002/S006 5/18/10 180-Day | Flair Endovascular Stent Graft | C.R. Bard Tempe, AZ 85281 | Approval of the post-approval protocol. |
| P060006/S006 5/28/10 180-Day | Express™ SD Renal Monorail™ Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for reinstatement of a secondary sterilization site formerly owned by Steris Isomedix Services, Inc. (Steris) located in Coventry, Rhode Island. |
| P060006/S010 5/11/10 Real-Time | Express™ SD Renal Monorail™ Premounted Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for material and specification changes to the strain relief. |
| P060008/S045 5/11/10 Real-Time | TAXUS® Liberté® OTW Paclitaxel-Eluting Coronary Stent System, Taxus Liberte Atom OTW Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for material and specification changes to the strain relief. |
| P060008/S047 5/17/10 Real-Time | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Maple Grove, MN 55311 | Approval for MR compatibility labeling changes to the Directions for Use (DFU) and Patient Information Guide (PG) for the TAXUS Liberté Monorail (MR) and Over-the-Wire (OTW) Stent Delivery Systems. |
| P060040/S010 5/7/10 180-Day | Heartmate II Left Ventricular Assist System | Thoratec Corporation Pleasanton, CA 94588 | Approval of the post-approval study protocol. |
| P070008/S011 5/7/10 180-Day | Evia/Entovis Pulse Generators | Biotronik, Inc. Lake Oswego, OR 97035 | Approval for the Evia/Entovis Pulse Generators. |
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 |
|---|---|---|---|
| P790007/S025 5/28/10 | Hancock® I Low Porosity and Modified Orifice Valved Conduit | Medtronic, Inc. Santa Ana, CA 92705 | Addition of Gorditos Meats as an alternate supplier. |
| P810046/S238 5/13/10 | Voyager® NC Coronary Dilatation Catheter | Abbott Vascular, Inc. Temecula, CA 92591 | Change in the extrusion process for the tubing used to manufacture the Voyager® NC Coronary Dilatation Catheter’s 3.50 mm through 5.00 mm balloons. |
| P830061/S051 5/19/10 | CapSure Sense, Vitatron | Medtronic, Inc. Mounds View, MN 55112 | Addition of a second source supplier of electrode components. |
| P840001/S152 5/20/10 | Restore Implantable Stimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Addition of the supplemental Automated Optical Inspection (AOI). |
| P840001/S153 5/27/10 | RestoreULTRA Implantable Neurostimulator | Medtronic Neuromodulation Minneapolis, MN 55432 | Change to qualify a connector rework process for the device manufacturing processes at Medtronic Puerto Rico Operations Company, Juncos, Puerto Rico. |
| P860004/S127 5/20/10 | Personal Therapy Manager | Medtronic Neuromodulation Minneapolis, MN 55432 | Addition of the supplemental Automated Optical Inspection (AOI). |
| P860019/S255 5/2710 | Apex™ Percutaneous Transluminal Coronary Angioplasty (PTCA) Dilatation Catheter | Boston Scientific Maple Grove, MN 55311 | Alternate sterilization cycle to be used at Isotron, Tullamore, Ireland. |
| P870078/S009 5/28/10 | Hancock® Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Addition of Gorditos Meats as an alternate supplier. |
| P890003/S190 5/14/10 | Carelink Programmer | Medtronic, Inc. Mounds View, MN 55112 | Change to the antenna support, manufacturing process changes related to the antenna support change, and changes to an antenna test. |
| P890064/S022 5/17/10 | digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test | Qiagen Gaithersburg, Inc. Gaithersburg, MD 20878 | Change in supplier for the reagent in the device. |
| P890064/S023 5/17/10 | digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test | Qiagen Gaithersburg, Inc. Gaithersburg, MD 20878 | Enabling the existing barcode reader configuration within the equipment software during the production of the device. |
| P890064/S024 5/17/10 | digene ® Hybrid Capture 2 (HC2) HPV DNA Test and digene® Hybrid Capture 2 (HC2) High Risk HPV DNA Test | Qiagen Gaithersburg, Inc. Gaithersburg, MD 20878 | Scale-up in the production of a component in the device. |
| P910073/S083 5/21/10 | Reliance Family of Leads | Boston Scientific Corporation St. Paul, MN 55112 | Replacement of existing automated measuring equipment. |
| P930039/S037 5/19/10 | CapSureFix Novus, Vitatron | Medtronic, Inc. Mounds View, MN 55112 | Addition of a second source supplier of electrode components. |
| P940031/S067 5/20/10 | Discovery SR and DR | Boston Scientific Corporation St. Paul, MN 55112 | Elimination of the outer sleeve wash step. |
| P950029/S052 5/26/10 | Symphony, Rhapsody, Reply, Reply (V2), and Esprit Family of Pacemakers | ELA Medical, Inc. Plymouth, MN 55441 | Change in location of the hybrid electronic module subcomponent manufacturing. |
| P950037/S080 5/13/10 | Sterox S and Dextrus Family of Implantable Pacemaker Pulse Generators and Programmers | Biotronik, Inc. Lake Oswego, OR 97035 | Change in packaging to the inner and outer bags of the sterilized stylet accessories. |
| P960009/S082 5/20/10 | Activa Family of Implantable Stimulators | Medtronic Neuromodulation Minneapolis, MN 55432 | Addition of the supplemental Automated Optical Inspection (AOI). |
| P960013/S059 5/13/10 | Tendril, Tendril ST, Tendril STS, and Optisense Leads | St. Jude Medical Sylmar, CA 91342 | Change in MCRD manufacturing process. |
| P960030/S030 5/13/10 | Passive Plus, Isoflex S & P, and Isoflex Optim Leads | St. Jude Medical Sylmar, CA 91342 | Change in MCRD manufacturing process. |
| P960040/S221 5/19/10 | Confient and Vitality HE Families of Pulse Generators | Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112 | Plating change to the reed switch component. |
| P960040/S222 5/19/10 | Ventak Prizm, Ventak Prizm 2, Vitality, Vitality HE, Vitality 2, Vitality AVT, and Confient Families of ICDs | Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112 | Multiple cleaning and component testing changes for the crystal oscillator component. |
| P960040/S223 5/20/10 | Confient and Vitality Families of ICDs | Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112 | Changes in the suppliers for thin-film resistors. |
| P960043/S071 5/5/10 | Perclose® AT 6F and Perclose® ProGlide™ Suture Medicated Closure Systems | Abbott Vascular, Inc. Redwood City, CA 94063 | Addition of an alternate supplier for two overmolded components. |
| D970003/S118 5/19/10 | Altrua Family of IPGs | Boston Scientific Corporation St. Paul, MN 55112 | Changes for hybrid assembly transfer, a new laser marking tool, an automated solder ball shear inspection test, and the removal of a pre-screening inspection. |
| D970003/S119 5/20/10 | Nexus I Entra SSIR, Nexus I Entra SSI, Nexus I Entra DDD, Nexus I Entra DDDR, Nexus I Plus DDDR, Discovery II SR, Insignia I Entra SSI, Insignia I Entra DDD, Insignia I Entra DDDR, Insignia I Entra SSIR, Insignia I Ultra DDDR, Insignia I Plus DDDR, Intelis II DR, and Intelis II SR | Boston Scientific Corporation St. Paul, MN 55112 | Elimination of the outer sleeve wash step. |
| P970004/S085 5/20/10 | Interstim iCOn Patient Programmer | Medtronic Neuromodulation Minneapolis, MN 55432 | Addition of the supplemental Automated Optical Inspection (AOI). |
| P970027/S008 5/13/10 | AxSYM Anti-HCV | Abbott Laboratories Diagnostic Division Abbott Park North, IL 60064 | Change to the efficacy testing performed on new incoming lots of conjugate concentrate for the device. |
| P970031/S029 5/28/10 | Freestyle® Aortic Root Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Addition of Gorditos Meats as an alternate supplier. |
| P980016/S236 5/12/10 | EnTrust ICD, Virtuoso ICD, Intrinsic, Marquis, Maximo, Maximo II DR/VR, Virtuoso II DR/VR, Secura DR ICD, Secura VR ICD | Medtronic, Inc. Mounds View, MN 55112 | Additional supplier for the plating process. |
| P980023/S040 5/13/10 | Linox SD and Linox S Family of ICD Pacing Leads | Biotronik, Inc. Lake Oswego, OR 97035 | Change in packaging to the inner and outer bags of the sterilized stylet accessories. |
| P980035/S165 5/12/10 | EnRhythm IPG | Medtronic, Inc. Mounds View, MN 55112 | Additional supplier for the plating process. |
| P980040/S033 5/20/10 | TECNIS® Multifocal One-Piece Intraocular Lens | Advanced Medical Optics, Inc. Santa Ana, CA 92705 | Change in the sterilization cycle parameters for the device. |
| P980043/S025 5/13/10 | Hancock® II Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Change to the valve holder assembly process and inspection documents. |
| P980043/S026 5/28/10 | Hancock® II Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Addition of Gorditos Meats as an alternate supplier. |
| P980049/S056 5/26/10 | Paradym Family of ICDs | ELA Medical, Inc. Plymouth, MN 55441 | Change in location of the hybrid electronic module subcomponent manufacturing. |
| P990001/S066 5/12/10 | DA+ C-Series, DA+ T-Series | Medtronic, Inc. Mounds View, MN 55112 | Additional supplier for the plating process. |
| P990037/S030 5/7/10 | Vascular Solutions Duett Sealing Device | Vascular Solutions Minneapolis, MN 55369 | Change in the quality control device used to monitor the sterilization process from an in-house manufactured sterilization process control device (SPCD) to a commercially purchased PCD. |
| P990064/S032 5/13/10 | Mosaic® Porcine Bioprosthesis | Medtronic, Inc. Sana Ana, CA 92705 | Change to the valve holder assembly process and inspection documents. |
| P990064/S033 5/28/10 | Mosaic® Porcine Bioprosthesis | Medtronic, Inc. Santa Ana, CA 92705 | Addition of Gorditos Meats as an alternate supplier. |
| P990066/S036 5/27/10 | Senographe Digital Mammography System | GE Healthcare Waukesha, WI 53188 | Change in supplier and replacement of obsolete computer systems. |
| P000006/S019 5/6/10 | Titan Inflatable Penile Prosthesis | Coloplast Corp. Minneapolis, MN 55411 | Use of an automated piece of equipment in dipping large size Titan cylinders. |
| P000039/S036 5/28/10 | Amplatzer® Septal Occluder | AGA Medical Corporation Plymouth, MN 55442 | Change in the supplier of the stitching yarn used in select Nitinol occlusion devices. |
| P010012/S234 5/20/10 | Cognis, Contak Renewal, Contak Renewal 3 RF, Contak Renewal 3 HE, Contak Renewal 3 RF HE, Contak Renewal 3, Contak Renewal 3 AVT HE, Contak Renewal 4 AVT, Contak Renewal 4 AVT HE, Livian LV1 SE, and Livian LV1 HE | Boston Scientific Corporation St. Paul, MN 55112 | Elimination of the outer sleeve wash step. |
| P010012/S240 5/19/10 | Livian, Renewal 3, Renewal 3RF, and Renewal 3 AVT Families of Pulse Generators | Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112 | Plating change to the reed switch component. |
| P010012/S241 5/19/10 | Contak Renewal, Contak Renewal 3, Contak Renewal 3 HE, Contak Renewal 3 RF, Contak Renewal 3 RF HE, Livian SE, and Livian HE Families of CRT-Ds | Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112 | Multiple cleaning and component testing changes for the crystal oscillator component. |
| P010012/S242 5/20/10 | Contak Renewal 3 and Livian Families of CRT-Ds | Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112 | Changes in the suppliers for thin-film resistors. |
| P010021/S018 5/20/10 | Vitros Immunodiagnostics Products Anti-HCV Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 | Addition of a new supplier of a raw material used in the manufacture of the Vitro Anti-HCV Calibrator. |
| P010031/S195 5/12/10 | Concerto CRT-D, InSync II Marquis, Consulta CRT-D, InSync II Protect, InSync III Marquis, InSync Marquis, InSync II Protect, Maximo II CRT-D | Medtronic, Inc. Mounds View, MN 55112 | Additional supplier for the plating process. |
| P010047/S003 5/25/10 | Neomend ProGel™ Pleural Air Leak Sealant | NeoMend, Inc. Irvine, CA 92618 | Modification of a test procedure used to determine the percent protein of human serum albumin in the component manufacturing process and for final release. |
| P020009/S063 5/13/10 | Express 2® Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Change to the software used during a step in the stent manufacturing process. |
| P020024/S029 5/28/10 | Amplatzer® Duct Occluder | AGA Medical Corporation Plymouth, MN 55442 | Change in the supplier of the stitching yarn used in select Nitinol occlusion devices. |
| P020047/S019 5/21/10 | Multi-Link Vision® OTW Coronary Stent System and Multi-Link Mini Vision® OTW Coronary Stent System | Abbott Vascular Temecula, CA 92591 | Change to the extrusion manufacturing process. |
| P030005/S062 5/21/10 | Contak Renewal TR | Boston Scientific Corporation St. Paul, MN 55112 | Change in test limits. |
| P030005/S063 5/19/10 | Contak Renewal TR Family of CRT-Ps | Boston Scientific Corporation Cardiac Rhythm Management St. Paul, MN 55112 | Multiple cleaning and component testing changes for the crystal oscillator component. |
| P030005/S064 5/20/10 | Contak Renewal TR | Boston Scientific Corporation St. Paul, MN 55112 | Elimination of the outer sleeve wash step. |
| P030009/S041 5/13/10 | Driver & Microdriver Coronary Stent Systems | Medtronic Vascular Santa Rosa, CA 95403 | Addition of process equipment. |
| P030025/S088 5/13/10 | TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Replacement of the final inspection camera with one that performs the existing catheter Final Inspection process at the SDS Final Inspection station. |
| P030025/S089 5/13/10 | TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Changes to process software. |
| P030025/S090 5/13/10 | TAXUS® Express 2® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Change to the software used during a step in the stent manufacturing process. |
| P030031/S029 5/27/10 | Navistar RMT Thermocool Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 | Addition of second source supplier of the Pebax 40D Tubing. |
| P040002/S028 5/13/10 | Powerlink® Stent Graft with IntuiTrak Delivery System | Endologix, Inc. Irvine, CA 92618 | Change to the hemostasis handle assembly of the device. |
| P040016/S056 5/13/10 | VeriFLEX® Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Change to the software used during a step in the stent manufacturing process. |
| P040016/S057 5/13/10 | VeriFLEX (Liberté®) Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Change from a manual in-process inspection to an automated in-process inspection. |
| P040036/S022 5/27/10 | Celsius RMT Thermocool Catheter | Biosense Webster, Inc. Diamond Bar, CA 91765 | Addition of second source supplier of the Pebax 40D Tubing. |
| P040040/S013 5/28/10 | Amplatzer® Muscular VSD Occluder | AGA Medical Corporation Plymouth, MN 55442 | Change in the supplier of the stitching yarn used in select Nitinol occlusion devices. |
| P040044/S031 5/4/10 | Mynx Vascular Closure Device | Access Closure, Inc. Mountain View, CA 04043 | Change to a component joining process. |
| P050007/S025 5/21/10 | StarClose SE® Vascular Closure System | Abbott Vascular, Inc Redwood City, CA 94063 | Addition of a post-cure process to the manufacturing of the Release Rod component. |
| P050010/S005 5/26/10 | ProDisc-L Total Disc Replacement | Synthes Spine West Chester, PA 19380 | New Mahr perthometer that uses a different software version than the existing Mahr perthometer used to measure surface toughness. |
| P050010/S006 5/26/10 | ProDisc-L Total Disc Replacement | Synthes Spine West Chester, PA 19380 | Upgrade of the Rofin Baasel Software, which controls the etching machine, from version 1.0.54 to 1.0.61. |
| P050023/S030 5/13/10 | Lumax Family of ICDs and CRT-Ds | Biotronik, Inc. Lake Oswego, OR 97035 | Change in packaging to the inner and outer bags of the sterilized stylet accessories. |
| P060006/S012 5/13/10 | Express® SD Renal Monorail® Premounted Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Change to the software used during a step in the stent manufacturing process. |
| P060008/S049 5/13/10 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Replacement of the final inspection camera with one that performs the existing catheter Final Inspection process at the SDS Final Inspection station. |
| P060008/S050 5/13/10 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Changes to process software. |
| P060008/S051 5/13/10 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Change to the software used during a step in the stent manufacturing process. |
| P060008/S052 5/13/10 | TAXUS® Liberté® Paclitaxel-Eluting Coronary Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Change from a manual in-process inspection to an automated in-process inspection. |
| P060022/S007 5/19/10 | Akreos® Posterior Chamber Intraocular Lens | Bausch & Lomb, Inc. Aliso Viejo, CA 92656 | Elimination of the Ophthalmic Irrigation Solution Specification of the lens storage solution. |
| P060027/S023 5/26/10 | Paradym Family of CRT-Ds | ELA Medical, Inc. Plymouth, MN 55441 | Change in location of the hybrid electronic module subcomponent manufacturing. |
| P070015/S034 5/14/10 | XIENCE V® and PROMUS™ Everolimus Eluting Coronary Stent Systems | Abbott Vascular Temecula, CA 92591 | Change to the balloon manufacturing process. |
| P070015/S035 5/21/10 | Promus™ OTW Everolimus-Eluting Coronary Stent System and Xience V® OTW Everolimus-Eluting Coronary Stent System | Abbott Vascular Temecula, CA 92591 | Change to the extrusion manufacturing process. |
| P090003/S001 5/13/10 | Express® LD Iliac Premounted Stent System | Boston Scientific Corporation Cardiovascular Maple Grove, MN 55311 | Change to the software used during a step in the stent manufacturing process. |
Summary of PMA Originals & Supplements Approved
Originals: 1
Supplements: 65
Summary of PMA Originals Under Review
Total Under Review: 82
Total Active: 34
Total On Hold: 48
Number Greater Than 180 Days: 6
Summary of PMA Supplements Under Review
Total Under Review: 591
Total Active: 386
Total On Hold: 205
Number Greater Than 180 Days: 17
Summary of All PMA Submissions Received
Originals: 3
Supplements: 79
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 65
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 144.7
FDA Time: 91.4 Days MFR Time: 53.3 Days
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