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PMA Final Decisions Rendered for October 2005 |
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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. Information about the PDF Reader is available.
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
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| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| P840001/S081 |
Medtronic Neurostimulation Systems |
Medtronic, Inc. |
Approval for the Model 3550-39 Titan™ Anchor Accessory Kit. |
| P860019/S203 |
PTCA Catheters |
Boston Scientific Corporation |
Approval for a manufacturing site located at Boston Scientific European Distribution Center (EDC), Kerkrade, The Netherlands. This facility will relabel and package various stents and PTCA Catheters. |
| P860057/S030 |
Carpentier-Edwards® PERIMOUNT® Pericardial Bioprosthesis, Models 2700, 2700TFX, 2800, 2800TFX, 3000, 3000TFX, 6900, 6900P (PERIMOUNT Plus™) |
Edwards Lifesciences |
Approval for the alternative 3.8 oz. size jar and the pre-printed cardboard carton. |
| P870056/S022 |
Carpentier-Edwards® Bioprosthesis, Models 2625, 6625 |
Edwards Lifesciences |
Approval for the alternative 3.8 oz. size jar and the pre-printed cardboard carton. |
| P870077/S020 |
Carpentier-Edwards® Duraflex® Low Pressure Bioprosthesis, Models 6625LP and 6625-ESR-LP |
Edwards Lifesciences |
Approval for the alternative 3.8 oz. size jar and the pre-printed cardboard carton. |
| P880027/S064 |
PTCA Catheters |
Boston Scientific Corporation |
Approval for a manufacturing site located at Boston Scientific European Distribution Center (EDC), Kerkrade, The Netherlands. This facility will relabel and package various stents and PTCA Catheters. |
| P890003/S089 |
All Pacemakers and Implantable Defibrillators supported by CareLink and related Monitors |
Medtronic, Inc. |
Approval to activate the capability to remotely update the software in CareLink Monitor Models 2490A/D/E/G/H/J, the Model 2030A BatteryCheck Monitor and the Model 2020A CardioSight Reader with the software versions specified in Attachment A for use with the pacemakers and implantable defibrillators as specified in the attachment. |
| P900061/S057 |
All Pacemakers and Implantable Defibrillators supported by CareLink and related Monitors |
Medtronic, Inc. |
Approval to activate the capability to remotely update the software in CareLink Monitor Models 2490A/D/E/G/H/J, the Model 2030A BatteryCheck Monitor and the Model 2020A CardioSight Reader with the software versions specified in Attachment A for use with the pacemakers and implantable defibrillators as specified in the attachment. |
| P920047/S028 |
Maestro 3000™ Cardiac Ablation System |
Boston Scientific Corporation |
Approval for modification to the hardware, software, and new accessories of the EPT-1000® series of Cardiac Ablation Systems. The device, as modified, will be marketed under the trade name Maestro 3000™ Cardiac Ablation System and is indicated for use, in cardiac ablation procedures, with standard and high-power BSC cardiac ablation catheters such that the physician is referred to the individual Instructions for Use for catheter compatibility to the Maestro 3000™ Cardiac Ablation System. The Boston Scientific Corporation Ablation Catheters which are compatible with the Maestro™ Cardiac Ablation System are the Blazer II™/Blazer II HTD™, Blazer II XP™, Blazer RPM ™, Blazer XP RPM™, Polaris T™/Polaris T™ HTD, Chilli II™, and SteeroCath-T®. |
| P930031/S024 |
Wallstent Endoprosthesis with Unistep Plus Delivery System (TIPS) |
Boston Scientific Corporation |
Approval for a manufacturing site located at Boston Scientific European Distribution Center (EDC), Kerkrade, The Netherlands. This facility will relabel and package various stents and PTCA Catheters. |
| P930036/S003 |
ACS:180®/ADVIA Centaur AFP Immunoassay |
Bayer Healthcare, LLC |
Approval for the ACS:180® and the Centaur® AFP assays on the ADVIA Centaur® CP System. The device, as modified, will be marketed under the trade name ADVIA Centaur® CP AFP and is indicated for in vitro diagnostic use in the quantitative determination of alpha-fetoprotein (AFP) in 1) Human serum and in amniotic fluid from specimens obtained at 15 and 20 weeks gestation, as an aid in detecting open neural tube defects (NTDs) when used in conjunction with ultrasonography and amniography testing 2) Human serum, as an aid in managing non-seminomatous testicular cancer when used in conjunction with physical examination, histology/pathology, and other clinical evaluation procedures, using the (Bayer) System. |
| P940019/S019 |
Wallstent Endoprosthesis with Unistep Plus Delivery System (Iliac) |
Boston Scientific Corporation |
Approval for a manufacturing site located at Boston Scientific European Distribution Center (EDC), Kerkrade, The Netherlands. This facility will relabel and package various stents and PTCA Catheters. |
| P950021/S007 |
ADVIA® Centaur CP PSA assay |
Bayer HealthCare LLC |
Approval for transfer of the assay to a new Bayer platform, the ADVIA® Centaur CP System. The ADVIA Centaur CP PSA assay is intended to quantitatively measure Prostate-Specific-Antigen (PSA) in human serum using the ADVIA Centaur CP System. |
| P960030/S013 |
Isoflex S 1646T Lead |
St. Jude Medical, CRMD |
Approval for an alternate manufacturing process and material for the Isoflex S 1646T lead. |
| P970043/S021 |
LADARVision® 4000 Excimer Laser System |
Alcon Laboratories, Inc. |
Approval for a software calibration “lock-out” feature wherby the laser system will be “locked-out” to prevent the initiation of surgery more than 60 minutes after the last system calibration, a “countdown clock” on the computer monitor which will provide the user with feedback on the remaining time before the system will lock-out, and a software bug fix to correct a certain “bug” from occurring under certain conditions if the Ruler Tool was used with the tracker engaged during surgery. |
| P970051/S034 |
Nucleus 24 Cochlear Implant System |
Cochlear Americas |
Approval for an alternative cable and connector (also known as shoe) to be used with the previously approved Nucleus Freedom Bodyworn Processor. The alternative cable/shoe has been designed to be compatible with wireless FM communication systems manufactured by Phonak Hearing Systems. |
| P970061/S021 |
Radius Coronary Stent with Delivery System |
Boston Scientific Corporation |
Approval for a manufacturing site located at Boston Scientific European Distribution Center (EDC), Kerkrade, The Netherlands. This facility will relabel and package various stents and PTCA Catheters. |
| P980003/S016 |
Maestro 3000™ Cardiac Ablation System |
Boston Scientific Corporation |
Approval for modification to the hardware, software, and new accessories of the EPT-1000® series of Cardiac Ablation Systems. The device, as modified, will be marketed under the trade name Maestro 3000™ Cardiac Ablation System and is indicated for use, in cardiac ablation procedures, with standard and high-power BSC cardiac ablation catheters such that the physician is referred to the individual Instructions for Use for catheter compatibility to the Maestro 3000™ Cardiac Ablation System. The Boston Scientific Corporation Ablation Catheters which are compatible with the Maestro™ Cardiac Ablation System are the Blazer II™/Blazer II HTD™, Blazer II XP™, Blazer RPM ™, Blazer XP RPM™, Polaris T™/Polaris T™ HTD, Chilli II™, and SteeroCath-T®. |
| P980009/S013 |
Magic Wallstent Endoprosthesis |
Boston Scientific Corporation |
Approval for a manufacturing site located at Boston Scientific European Distribution Center (EDC), Kerkrade, The Netherlands. This facility will relabel and package various stents and PTCA Catheters. |
| P980016/S056 |
All Pacemakers and Implantable Defibrillators supported by CareLink and related Monitors |
Medtronic, Inc. |
Approval to activate the capability to remotely update the software in CareLink Monitor Models 2490A/D/E/G/H/J, the Model 2030A BatteryCheck Monitor and the Model 2020A CardioSight Reader with the software versions specified in Attachment A for use with the pacemakers and implantable defibrillators as specified in the attachment. |
| P980033/S013 |
Wallstent Endoprosthesis with Unistep Plus Delivery System (Venous) |
Boston Scientific Corporation |
Approval for a manufacturing site located at Boston Scientific European Distribution Center (EDC), Kerkrade, The Netherlands. This facility will relabel and package various stents and PTCA Catheters. |
| P980035/S047 |
All Pacemakers and Implantable Defibrillators supported by CareLink and related Monitors |
Medtronic, Inc. |
Approval to activate the capability to remotely update the software in CareLink Monitor Models 2490A/D/E/G/H/J, the Model 2030A BatteryCheck Monitor and the Model 2020A CardioSight Reader with the software versions specified in Attachment A for use with the pacemakers and implantable defibrillators as specified in the attachment. |
| P990019/S003 |
BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 |
DUSA Pharmaceuticals, Inc. |
Approval of an alternate manufacturing site located at DUSA Pharmaceuticals, Inc., Wilmington, Massachusetts. |
| P990055/S008 |
Bayer ADVIA IMS® Complexed PSA Assay |
Bayer Healthcare, LLC |
Approval of the ACS:180® and the Centaur® Complexed PSA (cPSA) assays on the ADVIA Centaur® CP System. The device, as modified, will be marketed under the trade name ADVIA Centaur® CP cPSA and is indicated: The in vitro diagnostic assay is intended to quantitatively measure complexed prostate-specific antigen (cPSA) in human serum using the ADVIA Centaur® System. The assay is indicated for the measurement of serum complexed PSA in conjunction with digital rectal exam (DRE) as an aid in the detection of prostate cancer in men aged 50 years or older. Biopsy of the prostate is required for the diagnosis of prostate cancer. The assay is further indicated as an aid in the management (monitoring) of prostate cancer patients. |
| P990066/S022 |
GE Senographe DS and 200D Full Field Digital Mammography System |
GE Healthcare |
Approval to add labeling alerting user that images may be displayed in a manner different from that specified in MQSA requirements. |
| P990081/S002 10/21/05 Real-Time |
PATHWAY® HER-2/Neu (Clone CD11) Primary Antibody | Ventana Medical Systems, Inc. Tucson, AZ 85737 |
Approval of labeling changes for the PATHWAY® HER-2/Neu (Clone CD11) in the “intended use” section, addition of an “Optional Equipment Not Provided” section and changes to the “Principles and Procedures” section to reflect the addition of Tripath Imaging VIAS instrument to be used in conjunction with the Ventana PATHWAY® HER 2 assay as an optional accessory. The device, as modified, will be marketed under the same trade name PATYHWAY® HER-2/Neu (Clone CD11) and is indicated: Ventana Medical Systems, Inc.’s (Ventana) PATHWAY HER 2 (Clone CD11) is a mouse monoclonal antibody intended for laboratory use for the semi-quantitative detection of c-erbB2- antigen in sections of formalin fixed, paraffin embedded normal and neoplastic tissue on a Ventana automated immunohistochem-istry slide staining device. It is indicated as an aid in the assessment of breast cancer patients for whom Herceptin® treatment is considered. NOTE: All of the patients in the Herceptin® clinical trials were selected using a clinical trial assay. None of the patients in those trials were selected using PATHWAY HER 2. The PATHWAY HER 2 was compared to the DAKO HercepTest® on an independent sample and found to provide acceptably concordant results. The actual correlation of PATHWAY HER 2 to clinical outcome has not been established. The Ventana Image Analysis System (VIAS) is adjunctive optional computer-assisted image analysis system functionally connected to an interactive microscope. It is intended for use as an aid to the pathologist in the detection classification and counting of cells of interest based on market intensity, size and shape using appropriate controls to assure the validity of the VIAS scores. |
| P000007/S009 10/7/05 Real-Time |
Edwards Prima Plus Stentless Bioprosthesis, Modes 2500P | Edwards Lifesciences Irvine, CA 92614 |
Approval for the alternative 3.8 oz. size jar and the pre-printed cardboard carton. |
| P000039/S010 10/13/05 Real-Time |
AMPLATZER® Septal Occluder (ASO) Device | AGA Medical Corporation Golden Valley, MN 55427 |
Approval for changes to the labeling to support compatibility of the devices with MR environments up to 3.0 Tesla. The device, as modified, will be marketed under the trade name AMPLATZER® Septal Occluder (ASO) Device with the following indications for use: The AMPLATZER® Septal Occluder (ASO) Device is indicated for the occlusion of atrial septal defects (ASD) in secundum position. The ASO device is also indicated in patients who have undergone a fenestrated Fontan procedure and who now require closure of the fenestration. Patients indicated for ASD closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (i.e., 1.5:1 degree of left to right shunt or RV enlargement). |
| P010025/S007 10/31/05 180-Day |
Selenia Full Field Digital Mammography System | Hologic, Inc. Bedford, MA 01730 |
Approval for a change in the structure of the a-Selenia TFT image receptor to reduce image ghosting. |
| P010029/S002 10/20/05 Real-Time |
Euflexxa™ | Ferring Pharmaceuticals, Inc. Suffern, NY 10901 |
Approval for changing the trade name o the product from Nuflexxa™ to Euflexxa™. The device is indicated for the treatment of pain in osteoarthritis (OA) of the knee in patients who have failed to respond adequately to conservative non-pharmacologic therapy and to simple analgesics (e.g., acetaminophen). |
| P010031/S026 10/20/05 Real-Time |
All Pacemakers and Implantable Defibrillators supported by CareLink and related Monitors | Medtronic, Inc. Minneapolis, MN 55432 |
Approval to activate the capability to remotely update the software in CareLink Monitor Models 2490A/D/E/G/H/J, the Model 2030A BatteryCheck Monitor and the Model 2020A CardioSight Reader with the software versions specified in Attachment A for use with the pacemakers and implantable defibrillators as specified in the attachment. |
| P010041/S009 10/7/05 Real-Time |
Carpentier-Edwards® Supraannular (S.A.V.) Bioprosthesis, Model 2650 (and model 6650 which is not available in the US) | Edwards Lifesciences Irvine, CA 92614 |
Approval for the alternative 3.8 oz. size jar and the pre-printed cardboard carton. |
| P010054/S002 10/6/05 Special |
Elecsys Anti-HBs Immunoassay and Elecsys PreciControl Anti-HBs | Roche Diagnostics Corporation Indianapolis, IN 46250 |
Approval for change in quality controls that add a new specification, or otherwise provide additional assurance of purity, identity, strength, or reliability of the Elecsys Anti-HBs Immunoassay and Elecsys PreciControl Anti-HBs. |
| P010059/S002 10/14/05 180-Day |
Morcher® Cionni Capsular Tension Rings (Types 1L, 2L, and 2C) | Morcher GmbH Centerville, MA 02632 |
Approval for the Morcher® Cionni Capsular Tension Rings (Types 1L, 2L, and 2C). The device is indicated for the stabilization of the crystalline lens capsule in the presence of weak or partially absent zonules in adult patients undergoing cataract extraction with intraocular lens implantation. Conditions associated with weak or partially absent zonules may include primary zonular weakness (e.g., Marfan’s Syndrome), secondary zonular weakness (e.g., trauma or vitrectomy), cases of zonulysis, cases of pseudoexfoliation and cases of Marchesani’s Syndrome. |
| P010068/S007 10/21/05 180-Day |
Navistar DS and Celsius DS Diagnostic/Ablation Catheters | Biosense Webster, Inc. Diamond Bar, CA 91765 |
Approval for alternate sterilization site located at Steris Isomedix Services, San Diego, California, for the Interface Cables (part numbers D-1195-xx) for ablation catheters. |
| P020009/S021 10/31/05 |
TAXUS Express/Express2 MR & OTW Coronary Stent System | Boston Scientific Corporation Cardiovascular Division Maple Grove, MN 55311 |
Approval for a manufacturing site located at Boston Scientific European Distribution Center (EDC), Kerkrade, The Netherlands. This facility will relabel and package various stents and PTCA Catheters. |
| P020023/S012 10/21/05 135-Day |
Restylane | Q-MED Scandinavia, Inc. Princeton, NJ 08540 |
Approval for performing the protein testing in-house at the Q-Med Quality Control Laboratory and to change the test method so as to allow for the detection of lower amounts of protein. The device, as modified, will be marketed under the trade name Restylane and is indicated as an injectable gel for aesthetic use. |
| P020024/S005 10/13/05 Real-Time |
AMPLATZER® Duct Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Approval for changes to the labeling to support compatibility of the devices with MR environments up to 3.0 Tesla. The device, as modified, will be marketed under the trade name AMPLATZER® Duct Occluder Device with the following indications for use: The AMPLATZER® Duct Occluder Device is indicated for the non-surgical closure of patent ductus arteriosus (PDA). |
| P020025/S012 10/18/05 180-Day |
Maestro 3000™ Cardiac Ablation System | Boston Scientific Corporation San Jose, CA 95134 |
Approval for modification to the hardware, software, and new accessories of the EPT-1000® series of Cardiac Ablation Systems. The device, as modified, will be marketed under the trade name Maestro 3000™ Cardiac Ablation System and is indicated for use, in cardiac ablation procedures, with standard and high-power BSC cardiac ablation catheters such that the physician is referred to the individual Instructions for Use for catheter compatibility to the Maestro 3000™ Cardiac Ablation System. The Boston Scientific Corporation Ablation Catheters which are compatible with the Maestro™ Cardiac Ablation System are the Blazer II™/Blazer II HTD™, Blazer II XP™, Blazer RPM ™, Blazer XP RPM™, Polaris T™/Polaris T™ HTD, Chilli II™, and SteeroCath-T®. |
| P020031/S002 10/14/05 Real-Time |
Microsulis Microwave Endometrial Ablation (MEA) System | Microsulis Medical Ltd. Denmead Hampshire, UK PO7 6XP 02451 |
Approval for revised patient labeling. |
| P030011/S001 10/26/05 180-Day |
Syncardia Temporary CardioWest Total Artificial Heart (TAH-t) | Syncardia Systems, Inc. Tucson, AZ 85713 |
Approval of the post-approval study for the device. |
| P030025/S016 10/31/05 |
TAXUS Express/Express2 MR & OTW Coronary Stent System | Boston Scientific Corporation Cardiovascular Division Maple Grove, MN 55311 |
Approval for a manufacturing site located at Boston Scientific European Distribution Center (EDC), Kerkrade, The Netherlands. This facility will relabel and package various stents and PTCA Catheters. |
| P030026/S008 10/21/05 Special |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Approval for the change that addresses the addition of a Caution statement in the VITROS Anti-HBc IgM Reagent Pack Instructions for Use. |
| P030054/S008 10/12/05 180-Day |
Merlin™ Patient Care System for use with the Affinity/Integrity, Photon and Atlas+ Pulse Generators and the Pacing System Analyzer (PSA) application | St. Jude Medical Cardiac Rhythm Management Division Sylmar, CA 91342 |
Approval for the Merlin™ Patient Care System with the Model 3330 Version 1.0 Software. |
| P040029/S001 10/14/05 180-Day |
JSZ Orthokeratology Contact Lenses for Overnight Wear | Szabocsik and Associates Chicago, IL 60601 |
Approval for a protocol of acceptable procedures to allow one or more independent finishing laboratories to manufacture and distribute finished RGP contact lenses for overnight Orthokeratology made from lens blanks. |
| P040034/S001 10/25/05 Real-Time |
DuraSeal® Dural Sealant System | Confluent Surgical, Inc. Waltham, MA 02451 |
Approval for an extension of the product expiration date to 18 months. |
| P040038/S001 10/12/05 180-Day |
Xact® Carotid Stent System | Abbott Vascular Devices Redwood City, CA 94063 |
Approval of the post-approval study. |
| APPLICATION NUMBER / DATE of APPROVAL | DEVICE TRADE NAME | COMPANY NAME CITY, STATE, & ZIP | DEVICE DESCRIPTION / INDICATIONS |
| N17600/S023 |
Avitene® Microfibrillar Collagen Hemostat (MCH) Four family |
Davol, Inc. |
Manufacturing process changes for the Avitene Microfibrillar Collagen Hemostat (MCH) families of devices. |
| P790017/S084 |
NC Stormer OTW Balloon Dilatation Catheter |
Medtronic Vascular, Inc. |
Change which would increase the length of the distal
outer shaft of NC Stormer OTW Balloon Dilatation Catheter from |
| P790019/S020 |
ABBOTT IMx HAVAB®-M List 2263 |
Abbott Laboratories Diagnostics Division |
Changes in quality controls that add a new specification, implemented to improve manufacturability without compromising product performance. |
| P800002/S015 |
Avitene® Microfibrillar Collagen Hemostat (MCH) family |
Davol, Inc. |
Manufacturing process changes for the Avitene Microfibrillar Collagen Hemostat (MCH) families of devices. |
| P880086/S109 |
Affinity, Identity, Integrity and Entity Implantable Cardioverter Defibrillators |
St. Jude Medical Cardiac Rhythm Management Division |
Alternate vendor of quadpolar feedthrough assembly for use with Affinity, Identity, Integrity and Entity family of ICDs. |
| P880091/S019 10/19/05 |
Elastic Lens™ Single-Piece Silicone Posterior Chamber IOL | Staar Surgical Company Monrovia, CA 91016 |
Removal of the cytotoxicity testing on polymer raw materials before QC release to manufacturing. |
| P910023/S083 10/17/05 |
Implantable Cardioverter Defibrillator Devices (ICD and CRT-D) | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Elimination of a redundant weld operation during the assembly of the high voltage capacitor for the ICD/CRT-D devices. |
| P910073/S056 10/17/05 |
Reliance Leads | Guidant Corporation St. Paul, MN 55112 |
Additional supplier for the tip seal component. |
| P920047/S029 10/6/05 |
Blazer II, SteeroCath T, Blazer RPM Cardiac Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Modifications to manufacturing procedures and manufacturing instructions. |
| P000029/S014 10/28/05 |
Deflux® Syringe | Q-MED Scandinavia, Inc. Princeton, NJ 08540 |
Addition of an in-process control to replace a test procedure for usage during ordinary manufacturing. |
| P000029/S015 10/31/05 |
Deflux® Injectable Gel | Q-MED Scandinavia, Inc. Princeton, NJ 08540 |
Equipment and methods change in testing the pouch seal strength for the subject device. |
| P020025/S013 10/6/05 |
Blazer II XP, Blazer XP RPM Cardiac Ablation Catheters | Boston Scientific Corporation San Jose, CA 95134 |
Modifications to manufacturing procedures and manufacturing instructions. |
| P020026/S015 10/6/05 |
Cordis CYPHER™ Sirolimus-eluting Coronary Stent | Cordis Corporation Miami Lakes, FL 33014 |
Change from a manual measurement to an automated process. |
| P030005/S020 10/12/05 |
Contak Renewal TR | Guidant Corporation Cardiac Rhythm Management St. Paul, MN 55112 |
Change in the manufacturing process sequence of the Contak Renewal TR virgin hybrids. |
| P030006/S007 10/6/05 |
Prolieve Thermodilatation System | Celsion Columbia, MD 21046 |
Change in manufacturing process to reduce in-process waste. |
| P030025/S023 10/6/05 |
Taxus Express 2™ Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Widening of the upper tolerance of the in-process stent to marker band specification for the device. |
| P030054/S012 10/17/05 |
Implantable Cardioverter Defibrillator Devices (ICD and CRT-D) | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Elimination of a redundant weld operation during the assembly of the high voltage capacitor for the ICD/CRT-D devices. |
| P040016/S006 10/28/05 |
Liberté™ Coronary Stent System | Boston Scientific Corporation Maple Gove, MN 55311 |
Manufacturing process change to the distal tip weld process and inspection criteria of the Liberté™ Coronary Stent System. |
Summary of PMA Originals & Supplements Approved
Originals: 0
Supplements: 47
Summary of PMA Originals Under Review
Total Under Review: 92
Total Active: 38
Total On Hold: 54
Number Greater Than 180 Days: 4
Summary of PMA Supplements Under Review
Total Under Review: 347
Total Active: 179
Total On Hold: 168
Number Greater Than 180 Days:
Summary of All PMA Submissions Received
Originals: 1
Supplements: 97
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): 100.3
FDA Time: 49.9 Days MFR Time: 49.7 Days
Updated June 4, 2007
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