Some of the documents on this section of the CDRH Website are available only in PDF format and may not be accessible to those with certain disabilities. If you cannot access the documents you are interested in, please use the accessibility link for assistance. 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. Information about the PDF Reader is available.
PMA Original Approvals
| P030047 9/22/06 |
Cordis PRECISE® Nitinol Stent System | Cordis Corporation Warren, NJ 07059 |
Approval for the Cordis PRECISE® Nitinol Stent System (5.5 Fr and 6.0 Fr sizes, over-the-wire configuration). This device is indicated for use in conjunction with the ANGIOGUARD XP Emboli Capture Guidewire for the treatment of patients at high risk for adverse events from carotid endarterectomy (defined in the IFU) who require carotid revascularization and meet the criteria outlined below: 1) Patients with neurological symptoms and ≥50% stenosis of the common or internal carotid artery by ultrasound or angiogram OR patients without neurological symptoms and ≥80% stenosis of the common or internal carotid artery by ultrasound or angiogram, AND 2)Patients must have a vessel diameter of 4-9mm at the target lesion. The vessel distal to the target lesion must be within the range of 3mm and 7.5mm to allow for placement of the ANGIOGUARD XP Emboli Capture Guidewire. |
| P050038 9/26/06 |
Arista™ AH Absorbable Hemostat | Medafor, Inc. Minneapolis, MN 55430 |
Approval for the Arista™ AH Absorbable Hemostat. The device is indicated for use in surgical procedures (except neurological, ophthalmic, and urological) as an adjunctive hemostatic device to assist when control of capillary, venous, and arteriolar bleeding by pressure, ligature and other conventional procedures is ineffective or impractical. |
| P060007 9/7/06 |
ARCHITECT® HBsAg Reagent Kit ARCHITECT® HBsAg Calibrators ARCHITECT® HBsAg Controls ARCHITECT® HBsAg Confirmatory Reagent Kit ARCHITECT® HBsAg Confirmatory Manual Diluent |
Abbott Laboratories Abbott Park, IL 60064 |
Approval for the ARCHITECT ® HBsAg Reagents, ARCHITECT ® HBsAg Calibrators, ARCHITECT ® HBsAg Controls, ARCHITECT ® HBsAg Confirmatory Reagents, and ARCHITECT ® HBsAg Confirmatory Manual Diluent. The ARCHITECT ® HBsAg assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative detection of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma (dipotassium EDTA). The assay may also be used to screen for HBV infection in pregnant females to identify neonates who are at risk of acquiring hepatitis B during the perinatal period. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide presumptive evidence of infection with the hepatitis B virus (HBV) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection. The ARCHITECT ® HBsAg Calibrators are used for calibration of the ARCHITECT i System when the system is used for the qualitative detection of hepatitis B surface antigen (HBsAg) using the ARCHITECT ® HBsAg and HBsAg Confirmatory Reagent Kits. The performance of the ARCHITECT ® HBsAg Calibrators has not been established with any other HBsAg assays. The ARCHITECT HBsAg Controls are used for monitoring the performance of the ARCHITECT i System (reagents, calibrators, and instrument) when used for the qualitative detection of hepatitis B surface antigen (HBsAg) using the ARCHITECT HBsAg and HBsAg Confirmatory assays. The performance of the ARCHITECT HBsAg Controls has not been established with any other HBsAg assays. The ARCHITECT ® HBsAg Confirmatory Assay is a chemiluminescent microparticle immunoassay (CMIA) for the qualitative confirmation of the presence of hepatitis B surface antigen (HBsAg) in human adult and pediatric serum and plasma (dipotassium EDTA) that have been found to be repeatedly reactive by ARCHITECT ® HBsAg. Assay results, in conjunction with other laboratory results and clinical information, may be used to provide evidence of infection with the hepatitis B virus (HBV) (state of infection or associated disease not determined) in persons with signs and symptoms of hepatitis and in persons at risk for hepatitis B infection. The ARCHITECT ® HBsAg Confirmatory Manual Diluent is used for manually diluting specimens for testing on the ARCHITECT i System using the ARCHITECT ® HBsAg Confirmatory Reagent Kit. The performance of the ARCHITECT ® HBsAg Confirmatory Manual Diluent has not been established with any other HBsAg assays. |
| P060012 9/8/06 |
AxSYM CORE™ 2.0 and AxSYM CORE™ 2.0 Controls | Abbott Laboratories Abbott Park, IL 60064 |
Approval for the AxSYM CORE™ 2.0 and AxSYM CORE™ 2.0 Controls. This device is indicated for: The AxSYM CORE 2.0 is a microparticle enzyme immunoassay (MEIA) intended for the qualitative detection of total antibodies (IgG and IgM) to hepatitis B virus core antigen (anti‑HBc) in adult and pediatric serum (including serum collected in serum separator tubes) or plasma (collected in potassium EDTA, sodium citrate, sodium heparin, lithium heparin, or plasma separator tubes containing lithium heparin). The assay is used as an aid in the diagnosis of acute, chronic, or resolved hepatitis B virus (HBV) infection in conjunction with other laboratory results and clinical information. The AxSYM CORE™ 2.0 Controls are used for monitoring the performance of the AxSYM® System (reagent and instrument) when used for the qualitative detection of total antibodies to hepatitis B virus core antigen (anti‑HBc) when using the AxSYM CORE 2.0 Reagent Kit. The performance of the AxSYM CORE 2.0 Controls has not been established with any other anti-HBc assays. |
PMA Supplemental Approvals
| P810006/S022 9/20/06 180-Day |
CollaStat® Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for a manufacturing site located at Integra Neurosciences PR, Inc., Anasco, Puerto Rico for packaging and Steri-Tech, Inc., Salinas, Puerto Rico for sterilization. |
| P820021/S031 9/20/06 Real-Time |
Vifilcon A Soft Contact Lenses for Extended Wear | CIBA Vision Corporation Duluth, GA 30097 |
Approval for revised stability protocols. |
| P840062/S009 9/20/06 180-Day |
CollaCote Absorbable Collagen Wound Dressing | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for a manufacturing site located at Integra Neurosciences PR, Inc., Anasco, Puerto Rico for packaging and Steri-Tech, Inc., Salinas, Puerto Rico for sterilization. |
| P850010/S019 9/20/06 180-Day |
HeliStat® Absorbable Collagen Hemostatic Agents | Integra LifeSciences Corporation Plainsboro, NJ 08536 |
Approval for a manufacturing site located at Integra Neurosciences PR, Inc., Anasco, Puerto Rico for packaging and Steri-Tech, Inc., Salinas, Puerto Rico for sterilization. |
| P870038/S008 9/29/06 135-Day |
Starr-Edwards Silastic Ball Prosthesis | Edwards LifeSciences Irvine, CA 92614 |
Approval for a change in suppliers for a Polytetrafluourethy-lene (PTFE) rod used in the manufacture of the device. |
| P890003/S108 9/19/06 180-Day |
Various Families of Pacemakers, ICDs and CRT-Ds | Medtronic, Inc. Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a manufacturing site located at TriVirix Minneapolis, Inc., Milaca, Minnesota for the final testing, activating, labeling and packaging of the Model 2490H CareLink Monitor and the Model 2020A CardioSight Reader. |
| P900030/S009 9/21/06 180-Day |
Contigen® Bard® Collagen Implant | Inamed Corporation Santa Barbara, CA 93111 |
Approval for revised Directions for Use (DFU) that include information from the post-approval study on Cohort B. |
| P910023/S115 9/18/06 Real-Time |
Housecall Plus™ with Transmitter Software Version 3.0, Receiver Software Version 3.0 and Transmitter Hardware Version H | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Approval for the modifications to the St. Jude Medical Housecall Plus™ to add support for Atlas II and Epic II ICD families and to remove the surface ECG function. |
| P940031/S054 9/15/06 135-Day |
MERDIAN Family of Pacemakers | Guidant Corporation Saint Paul, MN 55112 |
Approval of the automation of a query review process and the addition of an automated release and signoff step. |
| P950029/S029 9/22/06 Real-Time |
Rhapsody Models 2210, 2510 and 2530 Pacemakers; Symphony Models 2250 and 2550 Pacemakers | ELA Medical, Inc. Plymouth, MN 55417 |
Approval for a counterbore being added to the ceramic insulator to accommodate the brazed gold for each feedthrough wire. |
| P960040/S125 9/15/06 135-Day |
PRIZM Family of Cardiac Resynchronization Therapy Devices (CRT-D) | Guidant Corporation Saint Paul, MN 55112 |
Approval of the automation of a query review process and the addition of an automated release and signoff step. |
| P970003/S070 9/5/06 Real-Time |
NeuroCybernetic Prosthesis (NCP) System | Cyberonics, Inc. Houston, TX 77058 |
Approval for a change from adding a strain relief grommet to the serial data cable of the Model 201 programming Wand during final assembly to molding an improved strain relief onto the serial data cable during its manufacture and changes to the tie-down used in the Model 302 Lead, the Model 303 Lead, and the Model 502 Accessory Pack. |
| D970003/S072 9/15/06 135-Day |
INSIGNIA Family of Pacemakers | Guidant Corporation Saint Paul, MN 55112 |
Approval of the automation of a query review process and the addition of an automated release and signoff step. |
| P980016/S083 9/19/06 180-Day |
Various Families of Pacemakers, ICDs and CRT-Ds | Medtronic, Inc. Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a manufacturing site located at TriVirix Minneapolis, Inc., Milaca, Minnesota for the final testing, activating, labeling and packaging of the Model 2490H CareLink Monitor and the Model 2020A CardioSight Reader. |
| P980035/S061 9/19/06 180-Day |
Various Families of Pacemakers, ICDs and CRT-Ds | Medtronic, Inc. Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a manufacturing site located at TriVirix Minneapolis, Inc., Milaca, Minnesota for the final testing, activating, labeling and packaging of the Model 2490H CareLink Monitor and the Model 2020A CardioSight Reader. |
| P980050/S024 9/13/06 180-Day |
GEM III AT with APP Device Model 7276 and Software Model 9974 | Medtronic, Inc. Cardiac Rhythm Disease Management Shoreview, MN 55126 |
Approval for modifications to the post approval study to update the RESPECT study protocol and related documentation to incorporate the EnRhythm Device (Model P15001DR), the EnRhythm Software (Model 9987), and the InCheck Patient Assistant (Model 2696). |
| P990066/S024 9/1/06 Special |
Senographe Essential System | GE Healthcare Milwaukee, WI 53188 |
Approval to add statements to the user and installation instructions to caution about the equipment that may not properly display or print the larger images produced by the Senographe Essential. |
| P000039/S013 9/21/06 180-Day |
AMPLATZER® Multi-Fenestrated Septal Occluder – “Cribriform” Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Approval for the AMPLATZER® Multi-Fenestrated Septal Occluder (“Cribriform” Occluder). The device is indicated for the closure of multi-fenestrated (Cribriform) atrial septal defects. |
| P010012/S129 9/15/06 135-Day |
RENEWAL Family of Pulse Generators | Guidant Corporation Saint Paul, MN 55112 |
Approval of the automation of a query review process and the addition of an automated release and signoff step. |
| P010019/S004 9/20/06 Real-Time |
Lotrafilcon A and Lotrafilcon B Soft Contact Lenses for Extended Wear | CIBA Vision Corporation Duluth, GA 30097 |
Approval for revised stability protocols. |
| P010031/S050 9/19/06 180-Day |
Various Families of Pacemakers, ICDs and CRT-Ds | Medtronic, Inc. Cardiac Rhythm Management Shoreview, MN 55126 |
Approval for a manufacturing site located at TriVirix Minneapolis, Inc., Milaca, Minnesota for the final testing, activating, labeling and packaging of the Model 2490H CareLink Monitor and the Model 2020A CardioSight Reader. |
| P020014/S013 9/19/06 Special |
Essure System | Conceptus, Inc. Mountain View, CA 94041 |
Approval for changes to the patient information booklet. |
| P020018/S010 9/7/06 180-Day |
36 mm diameter Zenith® FLEX™ AAA Endovascular Graft | Cook, Inc. Bloomington, IN 47402 |
Approval for the 36 mm diameter Zenith® FLEX™ AAA Endovascular Graft. |
| P020026/S021 9/7/06 135-Day |
Cordis Cypher Sirolimus-eluting Coronary Stent | Cordis Corporation Miami Lakes, FL 33014 |
Approval to include a second identity analytical test at the site in San German, Puerto Rico. |
| P020026/S022 9/28/06 135-Day |
Cordis Cypher Sirolimus-eluting Coronary Stent | Cordis Corporation Miami Lakes, FL 33014 |
Approval for changing a measurement system and process control methodology. |
| P030044/S002 9/27/06 180-Day |
Dake EGFR pharmDx™ Kit | Dako North America, Inc. Carpinteria, CA 93013 |
Approval for adding a new therapy VECTIBIX™ (panitumumab) to intended use. The device, as modified, will be marketed under the trade name Dako EGFR pharmDx™ Kit and is indicated for: The EGFR pharmDx™ assay is a qualitative immunohistochemical (IHC) kit system to identify epidermal growth factor receptor (EGFR) expression in normal and neoplatic tissues routinely-fixed for histological evaluatin. EGFR pharmDx specifically detects the EGFR (HER1) protein in EGFR-expressing cells. EGFR pharmDx is indicated as an aid in identifying colorectal cancer patients eligible for treatment with ERBITUX™ (cetuximab), or VECTIBIX™ (panitumumab). |
| P040012/S019 9/20/06 135-Day |
RX Acculink® and Acculink® Carotid Stent System | Abbott Vascular Devices Santa Clara, CA 95054 |
Approval for changes to the manufacturing process for bonding the tip bump to the guidewire lumen in RX Acculink® and Acculink Carotid Stents. |
| P040013/S003 9/22/06 180-Day |
GEM21S™ | BioMimetic Therapeutics, Inc. | Approval for a manufacturing site located at Novartis Corporation, Vacaville, California. |
| P040023/S006 9/20/06 135-Day |
Duraloc Option Ceramic Hip System | DePuy Orthopaedics, Inc. Warsaw, IN 46581 |
Approval for a chang in the order of the manufacturing steps, the addition of a new in-process test, and the addition of a redundant in-process test. |
| P040034/S005 9/15/06 180-Day |
DuraSeal® Dural Sealant System | Confluent Surgical, Inc. Waltham, MA 02451 |
Approval for a sterilization site located at BeamOne LLC, Lima, Ohio. |
| P040042/S004 9/20/06 Real-Time |
Therapy Dual 8 Catheter and IBI-1500T6 Cardiac Ablation Generator | Irvine Medical, Inc. Irvine, CA 92614 |
Approval for the addition of an Extender Module to the accessory list for the generator. The Extender Module will allow the user to place the generator up to an additional twenty feet from the patients. |
| P050007/S003 9/22/06 Real-Time |
Starclose™ Vascular Closure System | Abbott Vascular Devices Redwood City, CA 94063 |
Approval for: 1) Increasing the radii of the distal end of the Support Tube (Clip Delivery Tube) from 0.002 inches to 0.004 inches; 2) Adding a 45 degree chamfer to the proximal edge of the Distal Ring; and 3) Removing the “6F” notation on the Handle of the device. |
30-Day Notices (135 Day Supplement was not required)
| P810031/S028 9/14/06 |
Sodium Hyaluronate Ophthalmic Viscoelastic Devices – Healon®, Healon GV® and Healon5® | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Change to an automated process for the pre-treatment of the glass vials containing the viscoelastic material. |
| P810031/S029 9/13/06 |
Sodium Hyaluronate Ophthalmic Viscoelastic Devices – Healon®, Healon GV® and Healon5® | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Revision of the intrinsic viscosity test method for the sodium hyaluronate (5000, 7000) and related products. |
| P810031/S030 9/13/06 |
Sodium Hyaluronate Ophthalmic Viscoelastic Devices – Healon®, Healon GV® and Healon5® | Advanced Medical Optics, Inc. Santa Ana, CA 92705 |
Relocation of a quality control laboratory used for incoming inspection of raw materials (except sodium hyaluronate) and packaging components for Healon products to a different building at the same manufacturing site in the Uppsala, Sweden facility. |
| P860019/S212 9/29/06 |
PTCA Catheters | Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Removal of the six minute dwell time between the pre-shrink and port weld steps of the port pre-assembly process. |
| P880086/S127 9/21/06 |
Solus, Addvent, Solus II, Synchrony, Phoenix III, Trilogy, Affinity, Integrity, Entity, Identity, Verity and Victory Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Change to the silicone hydrohone mask tool used to manufacture the devices. |
| P880086/S128 9/29/06 |
Integrity ADx, Identity, Verity and Victory Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Change from an ion milling process to a wet etch removal process. |
| P910023/S116 9/21/06 |
Epic II/II+ DR/VR and Atlas II/II+ DR VR ICDs | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Change from a Delta Battery Voltage Test to a direct IBAT current measurement method and the elimination of a 14-day hold period during manufacturing. |
| P910023/S118 9/29/06 |
Cadence, Cadet, Contour, Angstrom, Profile, Photon, Epic, Atlas, Epic II, and Atlas II ICD Families | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Change from an ion milling process to a wet etch removal process. |
| P950029/S027 9/15/06 |
Symphony and ELA Rhapsody Models | ELA Medical, Inc. Plymouth, MN 55441 |
Change in the flux used for solder rework. |
| P950029/S028 9/15/06 |
Symphony 2550 and 2250 & Rhapsody 2530, 2510 and 2210 | ELA Medical, Inc. Plymouth, MN 55441 |
Change from cleaning with the Kerry machine to cleaning with the MBTech machine, and the addition of an MBTech cleaning step and visual inspection step. |
| P960052/S012 9/14/06 |
Dermabond® Topical Skin Adhesive Products | Closure Medical Corporation Raleigh, NC 27616 |
Change to the sterilization process. |
| P970031/S017 9/1/06 |
FREESTYLE Aortic Root Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Change to the supplier of the ploypropylene resin used for the injection molding of the final container lids. |
| P980006/S010 9/22/06 |
PureVision™, PureVision™ Toric and PureVision™ Multi-Focal (balafilcon A) Visibility Tinted Contact Lenses | Bausch & Lomb, Inc. Rochester, NY 14609 |
Alternative automated manufacturing process. |
| P980043/S010 9/1/06 |
HANCOCK II Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Change to the supplier of the ploypropylene resin used for the injection molding of the final container lids. |
| P990019/S004 9/21/06 |
BLU-U® Blue Light Photodynamic Therapy Illuminator, Model 4170 | DUSA Pharmaceuticals, Inc. Wilmington, MA 01887 |
Use of an alternate manufacturer for the timer assembly in the device. |
| P990064/S016 9/1/06 |
MOSAIC Porcine Bioprosthesis | Medtronic Heart Valves Santa Ana, CA 92705 |
Change to the supplier of the ploypropylene resin used for the injection molding of the final container lids. |
| P990081/S004 9/5/06 |
PATHWAY® HER-2/Neu (Clone CB11) primary Antibody | Ventana medical Systems, Inc. Tucson, AZ 85737 |
Change to eliminate the requirement for final acceptance testing of Anti-c-erbB-2 (cloneCB11) on two instrument systems. |
| P000039/S017 9/15/06 |
AMPLATZER® Septal Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Change to the LAL sampling plan. |
| P000044/S014 9/6/06 |
VITROS Immunodiagnostic Products HBsAg Reagent Pack and Calibrator, and the VITROS Immunodiagnostic Products HBsAg Confirmatory Kit | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Addition of a raw material specification, the modification of a raw material specification, and the modification of a component release specification. |
| P010050/S005 9/1/06 |
IMMULITE®/IMMULITE® 1000 HBsAg and IMMULITE® 2000 HBsAg | Diagnostic Products Corporation Los Angeles, CA 90045 |
Change to the reagent manufacturing process. |
| P020004/S015 9/21/06 |
GORE EXCLUDER® AAA Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
Change an acceptance criteria for a component used in the manufacture of the device. |
| P020009/S028 9/21/06 |
Express 2 MR & OTW Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Alternate method for removal o the distal heat shrink manufacturing aid of the device. |
| P020009/S031 9/29/06 |
Express 2 Coronary Stent System | Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Removal of the six minute dwell time between the pre-shrink and port weld steps of the port pre-assembly process. |
| P020024/S012 9/15/06 |
AMPLATZER® Duct Occluder | AGA Medical Corporation Golden Valley, MN 55427 |
Change to the LAL sampling plan. |
| P020036/S005 9/7/06 |
S.M.A.R.T.® CONTROL™ Nitinol Stent System | Cordis Corporation Warren, NJ 07059 |
Change in acceptance criteria of a quality assurance inspection for the device. |
| P030025/S034 9/21/06 |
Taxus Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Alternate method for removal of the distal heat shrink manufacturing aid of the device. |
| P030025/S037 9/29/06 |
Taxus Express 2 Paclitaxel-Eluting Coronary Stent System | Boston Scientific Cardiovascular Maple Grove, MN 55311 |
Removal of the six minute dwell time between the pre-shrink and port weld steps of the port pre-assembly process. |
| P030026/S011 9/12/06 |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrator | Ortho-Clinical Diagnostics, Inc. Rochester, NY 14626 |
Change in the assessment of coated well plates for streptavidin. |
| P030035/S020 9/29/06 |
Frontier II Pacemakers | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Change from an ion milling process to a wet etch removal process. |
| P030054/S035 9/21/06 |
Epic II HF and Atlas II HF CRT-Ds | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Change from a Delta Battery Voltage Test to a direct IBAT current measurement method and the elimination of a 14-day hold period during manufacturing. |
| P030054/S036 9/29/06 |
Epic HF, Atlas+ HR, Epic II HF and Atlas II HF CRT-D Families | St. Jude Medical Cardiac Rhythm Management Division Sunnyvale, CA 94086 |
Change from an ion milling process to a wet etch removal process. |
| P040012/S023 9/1/06 |
RX ACCULINK® and ACCULINK® Carotid Stent Systems | Abbott Vascular, formerly Guidant Corporation Santa Clara, CA 95054 |
Change to the product Acceptance Audit procedure for the RX ACCULINK® and ACCULINK® Carotid Stent Systems. |
| P040013/S006 9/8/06 |
GEM 21S® Growth Factor Enhanced Matrix | Biomimetic therapeutics, Inc. Franklin, TN 37067 |
Scaling up the manufacturing process to move from 2,000 unit batches to 20,000 unit batches. |
| P040016/S013 9/21/06 |
Liberté MR & OTW Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Remove the six minute dwell time afer the pre-shrink step for the Port Pre-assembly process of the device. |
| P040016/S014 9/21/06 |
Liberté MR & OTW Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Use of a manufacturing fixture for making the Port Pre-assembly of the device. |
| P040016/S015 9/21/06 |
Liberté MR & OTW Coronary Stent System | Boston Scientific Maple Grove, MN 55311 |
Alternate method for removal of the distal heat shrink manufacturing aid of the device. |
| P040043/S011 9/21/06 |
GORE TAG™ Thoracic Endoprosthesis | W.L. Gore & Associates Flagstaff, AZ 86001 |
Change an acceptance criteria for a component used in he manufacture of the TAG device. |
| P050012/S003 9/1/06 |
DexCom Short Term Glucose Sensor (STS) | DexCom, Inc. San Diego, CA 92121 |
Release criteria modification to the method used for final release criteria of the DexCom STS Sensor. |
| P050012/S004 9/22/06 |
DexCom Short Term Glucose Sensor (STS) | DexCom, Inc. San Diego, CA 92121 |
Modification of the application process to one of the layers in te multi-layer membrane system. |
| P060003/S001 9/11/06 |
AxSYM® AUSAB® | Abbott Laboratories Diagnostics Division Abbott Park, IL 60064 |
Implementation of additional testing at two different stages in the manufacturing process. |
Summary of PMA Originals & Supplements Approved
Originals: 8
Supplements: 46
Summary of PMA Originals Under Review
Total Under Review: 85
Total Active: 31
Total On Hold: 54
Number Greater Than 180 Days: 5
Summary of PMA Supplements Under Review
Total Under Review: 397
Total Active: 175
Total On Hold: 222
Number Greater Than 180 Days: 10
Summary of All PMA Submissions Received
Originals: 0
Supplements: 91
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 46
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 117.5
FDA Time: 95.5 Days MFR Time: 22.0 Days
Updated July 17, 2007
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