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PMA Final Decisions Rendered for June 2005 |
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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
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6/27/05 |
DakoCytomation c-Kit pharmDx™ |
DakoCytomation California, Inc. Carpinteria , CA 93013 |
Approval for the DakoCytomation c-Kit pharmDx™. DakoCytomation c-Kit pharmDx™ on the Dako Autostainer: The c-Kit pharmDx™ assay is a qualitative immunohistochemical (IHC) kit system used on the Dako Autostainer, for the identification of c-kit protein/CD117 antigen (c-kit protein) expression in normal and neoplastic formalin-fixed paraffin-embedded tissues for histological evaluation. The c-Kit PharmDx™ rabbit polyclonal antibodies specifically detect the c-kit protein in CD117 antigen-expressing cells. The c-Kit PharmDx™ is indicated as an aid in the differential diagnosis of gastrointestinal stromal tumors (GIST). After diagnosis of GIST, results from c-Kit PharmDx™ may be used as an aid in identifying those patients eligible for treatment with Gleevec™/Glivec® (imatinib mesylate). Results from hematoxylin and eosin (H&E) stains and a panel of antibodies can aid in the differential diagnosis of GIST. Interpretation must be made by a qualified pathologist, within the context of a patient’s clinical history, proper controls, and other diagnostic test. Dako Cytomation c-Kit PharmDx™ for Manual Use: the c-Kit PharmDx™ assay is a qualitative immunohistochemical (IHC) kit system used for the identification of c-kit protein/CD117 antigen (c-kit protein) expression in normal and neoplastic formalin-fixed paraffin-embedded tissues for histological evaluation. The c-Kit PharmDx™ rabbit polyclonal. Antibodies specifically detect the c-kit protein in CD117 antigen-expressing cells. The c-Kit PharmDx™ is indicated as an aid in the differential diagnosis of gastrointestinal stromal tumors (GIST). After diagnosis of GIST, results from c-Kit PharmDx™ may be used as an aid in identifying those patients eligible for treatment with Gleevec™/Glivec® (imatinib mesylate). Results from hematoxylin and eosin (H&E) stains and a panel of antibodies can aid in the differential diagnosis of GIST. Interpretation must be made by a qualified pathologist, within the context of a patient’s clinical history, proper controls, and other diagnostic test. |
|
6/14/05 |
GORE VIABAHN® Endoprosthesis |
W.L. Gore & Associates, Inc. Flagstaff , AZ 86002 |
Approval for the Gore VIABAHN Endoprosthesis. The device is indicated for improving blood flow in patients with symptomatic peripheral arterial disease in superficial femoral artery lesions with reference vessel diameters ranging from 4.8 to 7.5 mm. |
PMA Supplemental Approvals
P790005/S044 6/3/05 180-Day |
EBI Osteogen Implantable Growth Stimulator and EBI SPF Implantable Spinal Fusion Stimulator |
EBI, L.P. Parsippany , NJ 07054 |
Approval for a modified, smaller version of the devices. |
P790017/S083 6/22/05 Real-Time |
Sprinter MX 2 Balloon Dilatation Catheter |
Medtronic Vascular, Inc. Santa Rosa , CA 95403 |
Approval for adding a new catheter to the approved product line. The device, as modified, will be marketed under the trade name Sprinter Mx 2 and is indicated for balloon dilatation for the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion. The balloon dilatation catheter (balloon models 2.5 mm – 4.0 mm) is also indicated for the post-delivery expansion of balloon expandable stents. Note: Bench testing was conducted with the Sprinter Balloon Dilatation Catheter and marketed balloon expandable stents. Consideration should be taken when this device is used with different manufacturers’ stents due to differences I stent design. |
P830060/S058 6/20/05 Special |
Guidant Pulse Generators |
Guidant Corporation St. Paul , MN 55112 |
Approval for additional instruction for use for freeing stuck setscrews using the Bi-Directional Torque Wrench. |
P840001/S076 6/6/05 180-Day |
Spinal Cord Stimulation (SCS) Systems: Itrel 3® (Model 7425), Synergy™ (Model 7427), Synergy Versitrel™ (Model 7427V), Restore™ (Model 37711), Synergy Plus+™ (Model 7479), and Synergy Plus Compact+™ (Model 7479B) |
Medtronic Neurological Minneapolis , MN 55432 |
Approval for MRI labeling updates to the above listed Spinal Cord Stimulation (SCS) Systems. |
P850035/S030 6/3/05 180-Day |
EBI Osteogen Implantable Growth Stimulator and EBI SPF Implantable Spinal Fusion Stimulator |
EBI, L.P. Parsippany , NJ 07054 |
Approval for a modified, smaller version of the devices. |
P850079/S042 6/14/05 180-Day |
CooperVision, Inc. Hydrasoft, Hydrasoft Toric, Hydrasoft XW and Hydrasoft Toric XW (methafilcon B) Soft (Hydrophilic) Contact Lenses |
CooperVision, Inc. Scottville , NY 14546 |
Approval for a manufacturing site located at CooperVision, Inc., Scottsville , New York . |
P890003/S085 6/8/05 Real-Time |
Medtronic 2030A BatteryCheck Monitor to be used with the InSync II Marquis 7289, InSync Marquis Model 7277, Maximo DR Model 7278, Maximo VR Model 7232, Marquis DR Model 7274, and Marquis VR Model 7230 |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Medtronic 2030A BatteryCheck Monitor to be used with the InSync II Marquis 7289, InSync Marquis Model 7277, Maximo DR Model 7278, Maximo VR Model 7232, Marquis DR Model 7274, and Marquis VR Model 7230. |
P910007/S013 6/13/05 Real-Time |
Abbott IMx® Total PSA Assay |
Abbott Laboratories Abbott Park , IL 60064 |
Approval of the new method comparisons between the IMx® Total PSA assay and the IMx® PSA assay. The comparisons include regression analyses (Passing-Bablok and least squares linear regression) and bias analysis. The device, as modified, will be marketed under the same trade name IMx® Total PSA assay and is indicated as follows: The IMx® Total PSA assay is a Microparticle Enzyme Immunoassay (MEIA) for the quantitative measurement of total PSA (both free PSA and PSA complexed to alpha-1-antichymotrypsin) in human serum: 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. Prostatic biopsy is required for diagnosis of cancer. 2) as an adjunctive test to aid in the management of prostate cancer patients. |
P910023/S077 6/17/05 Real-Time |
ICD firmware version 6.6.7 for Epic™, Epic™ +, Atlas® and Atlas® +, and Model 3307 programmer software version 4.8.5 |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the ICD firmware version 6.6.7 for Epic Models V-233, V-239, V-239T, V-196, V-196T, V-338, V-337, Epic Plus Models V-236, V-196, Atlas and Atlas Plus Models V-242, V243, V-193, V-193C, V340, V-343; and Model 3307 programmer software version 4.8.5. |
P920047/S027 6/17/05 Real-Time |
Blazer II and Blazer II XP Cardiac Ablation Catheters |
Boston Scientific Corporation San Jose , CA 95134 |
Approval for the Blazer II and Blazer II XP catheters with modified mechanical performance specifications. |
P950022/S024 6/3/05 Real-Time |
Riata ST Lead Models 7000, 7001, and 7002 |
St. Jude Medical CRMD Sunnyvale , CA 94086 |
Approval for addition of the riata ST lead models 7000, 7001, and 7002 to the Riata defibrillation lead system. The devices, as modified, will be marketed under the trade name Riata ST Models 7000, 7001, and 7002 and are indicated for use with compatible pulse generators. |
P950037/S039 6/22/05 180-Day |
Protos DR/CLS and Protos VR/CLS |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for modifications to the labeling. |
|
6/30/05 Panel |
Onco-LIFE™ Endoscopic Light Source and Video Camera (Onco-Life™) |
Xillix® Technologies Corp. Richmond , BC , Canada V6V 2V4 |
Approval for the Onco-LIFE™ Endoscopic Light Source and Video Camera (Onco-Life™). This device is indicated for use with fluorescence imaging during bronchoscopy as an adjunct to white light imaging, to detect and localize tissue suspicious for moderate or severe dysplasia, carcinoma in situ, or invasive cancer in patients with suspected or previously treated lung cancer. |
P960030/S011 6/29/05 180-Day |
IsoFlex S Permanent pacing Lead Models Passive Plus DX |
St. Jude Medical/Cardiac Rhythm Management Div. Sylmar , CA 91342 |
Approval for a manufacturing site located at St. Jude Medical Puerto Rico, BS, Caguas , Puerto Rico 00725. |
P960040/S054 6/3/05 Real-Time |
Consult Programmer Software Application Model 2896 Version 2.0 |
Guidant Corporation St. Paul , MN 55112 |
Approval for the Consult Programmer Software Application Model 2896 Version 2.0. |
P970008/S026 6/16/05 180-Day |
Urologix Targis™ System for the Treatment of BPH |
Urologix, Inc. Minneapolis , MN 55447 |
Approval for a longer version of the Cooled ThermoCath microwave delivery catheter. The longer antenna is 37 mm compared to the 28 mm antenna in the currently approved Cooled ThermoCath Catheter. The device, as modified, will be marketed under the trade name Cooled ThermoCath 4.5+ and is indicated for men with prostatic urethral lengths of 4.5 cm or greater. |
P980016/S046 6/14/05 180-Day |
Medtronic EnTrust™ Models D153ATG, D153 DRG, D153VRC, D154ATG, D154DRG, D154VRC, Medtronic® Model 9987 Application Software and the Medtronic Model 2696 InCheck™ Patient Assistant |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Medtronic® EnTrust™ Models D153ATG, D153DRG, D153VRC, D154ATG, D154DRG, D154VRC, Medtronic® Model 9987 Application Software and the Medtronic Model 2696 InCheck Patient Assistant are indicated for use in ICD patients with atrial tachyarrhythmias, or who are at significant risk of developing atrial tachyarrhythmias. The EnTrust Models D153DRG, D153VRC and D154 DRG are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life-threatening ventricular arrhythmias. The EnTrust Models D153ATG and D1534ATG are intended to provide ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. In addition, the device is intended to provide pacing, cardioversion, and defibrillation for treatment of patients with: 1) Symptomatic, drug-refractory atrial fibrillation and/or 2) Life-threatening ventricular tachyarrhythmias. Atrial rhythm management features such as Atrial Rate Stabilization (ARS), Atrial Preference pacing (APP) and Post Mode Switch Overdrive (PMOP) are indicated for the suppression of atrial tachyarrhythmias in ICD-indicated patients with atrial septal lead placement and one or more of the above ICD indications. NOTES: a) Use of the device has not been demonstrated to decrease the morbidity related to atrial tachyarrhythmias. b) The effectiveness of high frequency burst pacing (Atrial-50Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 17% , and in terminating device classified atrial fibrillation (AF) was found to be 16.85% in the VT/AT population studied. c) The effectiveness of high frequency burst pacing (Atrial-50Hz Burst therapy) in terminating device classified atrial tachycardia (AT) was found to be 11.7% , and in terminating device classified atrial fibrillation (AF) was found to be 18.2% in the AF only population studied. |
P980016/S051 6/8/05 Real-Time |
Medtronic 2030A BatteryCheck Monitor to be used with the InSync II Marquis 7289, InSync Marquis Model 7277, Maximo DR Model 7278, Maximo VR Model 7232, Marquis DR Model 7274, and Marquis VR Model 7230 |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Medtronic 2030A BatteryCheck Monitor to be used with the InSync II Marquis 7289, InSync Marquis Model 7277, Maximo DR Model 7278, Maximo VR Model 7232, Marquis DR Model 7274, and Marquis VR Model 7230. |
P980035/S041 6/20/05 180-Day |
AT500 DDDRP Pacing System (Model AT500) and Model 9968 Software Post-market (RESPECT): Adding the EnRhythm Model P1501DR |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval to add the EnRhythm Model P1501DR to the post-approval study of the device. |
P990020/S019 6/24/05 Special |
Medtronic Vascular AneuRx Stent Graft with Xcelerant Delivery System |
Medtronic Vascular Santa Rasa , CA 95403 |
Approval to add an additional tensile test of the delivery system during the device manufacturing process. |
P990053/S012 6/24/05 135-Day |
Oxifirst™ Fetal Oxygen Saturation Monitoring System |
Nellcor Puritan Bennett, Inc. Pleasanton , CA 94588 |
Approval for an alternative vendor of raw cable and fetal sensor cable within the oximetry sensor. |
P990071/S005 6/6/05 180-Day |
Stockert 70 Radiofrequency Ablation Generator |
Biosense Webster, Inc. Diamond Bar , CA 91765 |
Approval for manual operation of the CoolFlow™ Irrigation Pump with the Biosense Webster ThermoCool™ Catheters. The device, as modified, will be marketed under the trade name CoolFlow™ Irrigation Pump. The CoolFlow™ Irrigation Pump and tubing set is a peristaltic irrigation pump designed for the delivery of saline solution when used in conjunction with the Stockert 70 RF Generator and the ThermoCool™ Irrigation Catheters. |
P000009/S015 6/22/05 Real-Time |
Belos, Cardiac Airbag, Lexos, and Xelos families of ICDs |
Biotronik, Inc. Lake Oswego , OR 97035 |
Approval for the Implant Control System (ICS) 3000 Programming System, using software Version 501.U for use with the Belos, Cardiac Airbag, Lexos, and Xelos families of ICDs. |
P000020/S009 6/16/05 Real-Time |
Bard Stinger®, Stinger® S, Stinger® M, and Stinger® SM Ablation Catheter |
C.R. Bard, Inc. Lowell , MA 01851 |
Approval for packaging changes for the Bard Stinger®, Stinger® S, Stinger® M, and Stinger® SM Ablation Catheter. |
P000021/S006 6/2/05 Special |
Dimension® TPSA Flex® Reagent Cartridge |
Dade Behring, Inc. Newark , DE 19714 |
Approval for the addition of the StreamLAB Analytical Workcell and Sample Transfer Module to the Dimension® RxL Max®. |
P010031/S023 6/8/05 |
Medtronic 2030A BatteryCheck Monitor to be used with the InSync II Marquis 7289, InSync Marquis Model 7277, Maximo DR Model 7278, Maximo VR Model 7232, Marquis DR Model 7274, and Marquis VR Model 7230 |
Medtronic, Inc. Minneapolis , MN 55432 |
Approval for the Medtronic 2030A BatteryCheck Monitor to be used with the InSync II Marquis 7289, InSync Marquis Model 7277, Maximo DR Model 7278, Maximo VR Model 7232, Marquis DR Model 7274, and Marquis VR Model 7230. |
P020002/S001 6/8/05 180-Day |
ThinPrep® Imaging System |
Cytyc Corporation Boxborough , MA 01719 |
Approval for a manufacturing site located at Cytyc Corporation, Marlborough , Massachusetts . |
P020006/S008 6/2/05 180-Day |
Enteryx® Injectable Bulking Solution Procedure Kit |
Boston Scientific Corporation Endoscopy Natick , MA 01760 |
Approval for a manufacturing site located at Boston Scientific Corporation, Wayne , New Jersey to conduct packaging and labeling operations. |
P020018/S005 6/9/05 180-Day |
Zenith® FLEX™ AAA Endovascular Graft with the H&LB One-Shot™ Introduction System |
Cook, Inc. Bloomington , IN 47402 |
Approval for modifications to the ancillary components for the Zenith FLEX AAA Endovascular Graft. |
P020025/S011 6/17/05 Real-Time |
Blazer II and Blazer II XP Cardiac Ablation Catheters |
Boston Scientific Corporation San Jose , CA 95134 |
Approval for the Blazer II and Blazer II XP catheters with modified mechanical performance specifications. |
P020026/S013 6/6/05 Special |
CYPHER Sirolimus-eluting Coronary Stent on the RAPTOR Over-the-Wire Delivery System or RAPTORRAIL Rapid Exchange Delivery System |
Cordis Corporation Miami Lakes , FL 33014 |
Approval for labeling changes to better inform patients and health care providers about the risks of early discontinuation of antiplatelet therapy and that responds to a letter sent to Cordis by FDA dated April 21, 2005 . |
P020027/S003 6/2/05 Special |
Dimension® FPSA Flex® Reagent Cartridge |
Dade Behring, Inc. Newark , DE 19714 |
Approval for the addition of the StreamLAB™ Analytical Workcell and Sample transfer Module to the Dimension® RxL Max®. |
P020045/S008 6/24/05 Special |
7F Freezor Cardiac CryoAblation Catheter & CCT.2 Cryoconsole System |
CryoCath Technologies, Inc. Kirkland , Quebec , Canada H9H 5H3 |
Approval for changes in quality controls of the incoming inspection of the stop button subassembly and the final inspection of the finished product. |
P020045/S009 6/27/05 Special |
7F Freezor Cardiac CryoAblation Catheter & CCT.2 Cryoconsole System |
CryoCath Technologies, Inc. Kirkland , Quebec , Canada H9H 5H3 |
Approval for changes in quality controls and manufacturing process that add a new specification for the stop button and the addition of a new validation test for the stop button. |
P030002/S003 6/6/05 180-Day |
Crystalens™ Model AT-45 Accommodating Intraocular Lens (IOL) |
Eyeonics, Inc. Aliso Viejo , CA 92656 |
Approval for a manufacturing site located at Life Sciences Outsourcing (LSO), Brea , California . |
P030006/S005 6/30/05 180-Day |
Prolieve™ Thermodilatation System Catheter and Heat Exchanger |
Celsion Corporation Columbia , MD 31046 |
Approval for Accellent Juarez (manufacturing site) located in, Chihuahua , Mexico ; Accellent El paso (warehouse) located in El Paso , Texas ; and Sterigenics International, Inc. (sterilizer) located in Santa Teresa , New Mexico . |
P030010/S002 6/20/05 Special |
Siemens Mammomat Novation DR Full Field Digital Mammography System |
Siemens Medical Solutions, Inc. Malvern , PA 19355 |
Approval for labeling changes to the Operators Manual which add or strengthen a contraindication, warning, precaution, or information about an adverse reaction and add or strengthen an instruction that is intended to enhance the safe use of the device. |
P030025/S020 6/29/05 Special |
TAXUS Express 2 ™ Paclitaxel-Eluting Coronary Stent System (Monorail, MR and Over-the-Wire, OTW) |
Boston Scientific Corporation Maple Grove , MN 55311 |
Approval for labeling (Directions for Use (DFU), patient guide and patient card) changes. |
P030054/S007 6/17/05 Real-Time |
ICD firmware version 6.6.7 for Epic™ HF, Epic™ + HF, Atlas® HF and Atlas® + HF, and Model 3307 programmer software version 4.8.5 |
St. Jude Medical Cardiac Rhythm Management Division Sunnyvale , CA 94086 |
Approval for the ICD firmware version 6.6.7 for Epic Models V-233, V-239, V-239T, V-196, V-196T, V-338, V-337, Epic Plus Models V-236, V-196, Atlas and Atlas Plus Models V-242, V243, V-193, V-193C, V340, V-343; and Model 3307 programmer software version 4.8.5. |
P040006/S001 6/16/05 180-day |
Charité Artificial Disc |
Depuy Spine, Inc. Raynham , MA 02767 |
Approval for a manufacturing sites located at DePuy ( Ireland ) Ltd, Cork , Ireland , for manufacturing and Isotron Plc, Marcus Close, Berkshire , United Kingdom , for Sterilization. |
30-Day Notices (135 Day Supplement was not required)
P880091/S018 6/28/05 |
Elastic Lens™ Single-Piece Silicone Posterior Chamber IOL |
Staar Surgical Company Monrovia , CA 91016 |
Alternate supplier for the UV Chromophore. |
P890014/S007 6/22/05 |
DiaSorin ETI-HA-IGMK PLUS |
DiaSorin S.p.A. Saluggia , Italy 13040 |
Change in the testing parameters used to determine specific attributes of raw materials for the device. |
P890019/S011 6/22/05 |
DiaSorin ETI-AB-HAVK PLUS |
DiaSorin S.p.A. Saluggia , Italy 13040 |
Change in the testing parameters used to determine specific attributes of raw materials for the device. |
P950032/S041 6/20/05 |
Apligraf |
Organogenesis, Inc. Canton , MA 02021 |
Changes to formulations used in the Apligraf manufacturing process. |
P960040/S055 6/14/05 |
VITALITY Implantable Cardioverter Defibrillator |
Guidant Corporation St. Paul , MN 55112 |
Use of an alternate epoxy in the manufacture of power modules for the VITALITY family of ICDs and the CONTAK RENEWAL family of CRT-D devices. |
P990020/S018 6/17/05 |
AneuRx Stent Graft with Xcelerant Delivery System |
Medtronic Vascular Santa Rose , CA 95403 |
Change in the manufacturing process implementing additional inspection and process clarifications to ensure proper function of the Xcelerant delivery System used to deliver the AneuRx Stent Graft. |
P990038/S010 6/22/05 |
DiaSorin ETI-MAK-2 PLUS |
DiaSorin S.p.A. Saluggia , Italy 13040 |
Change in the testing parameters used to determine specific attributes of raw materials for the device. |
P990041/S008 6/22/05 |
DiaSorin ETI-AB-EBK PLUS |
DiaSorin S.p.A. Saluggia , Italy 13040 |
Change in the testing parameters used to determine specific attributes of raw materials for the device. |
P990043/S009 6/22/05 |
DiaSorin ETI-EBK PLUS |
DiaSorin S.p.A. Saluggia , Italy 13040 |
Change in the testing parameters used to determine specific attributes of raw materials for the device. |
P990044/S007 6/22/05 |
DiaSorin ETI-CORE-IGMK PLUS |
DiaSorin S.p.A. Saluggia , Italy 13040 |
Change in the testing parameters used to determine specific attributes of raw materials for the device. |
P000032/S011 6/30/05 |
Her Option™ Cryoablation Therapy System |
American Medical System, Inc. Minnetonka , MN 55343 |
Use of mechanical crimping, instead of soldering, to form a joint that connects a capillary tube to a compressor circuit of the Cryostat subassembly. |
P000037/S005 6/3/05 |
On-X Prosthetic Heart Valve |
MCRI Austin , TX 78754 |
Change in the sewing ring cloth endotoxin testing to allow for combination of samples. |
P010012/S047 6/14/05 |
CONTAK RENEWAL cardiac Resynchronization Therapy Defibrillator |
CONTAK RENEWAL Cardiac Resynchronization Therapy Defibrillator |
Use of an alternate epoxy in the manufacture of power modules for the VITALITY family of ICDs and the CONTAK RENEWAL family of CRT-D devices. |
P020004/S012 6/7/05 |
EXCLUDER® Bifurcated Endoprosthesis |
W.L. Gore & Associated, Inc. Flagstaff , AZ 86001 |
Change to the joining method at a junction on the tubing. |
P020004/S013 6/14/05 |
EXCLUDER® Bifurcated Endoprosthesis |
W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Change form a manual cutting process to an automated cutting process for cuff components. |
P020009/S022 6/7/05 |
Express2™ Coronary Stent System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Tightening of acceptance criteria for an in-process inspection test for the matte finish length. |
P020018/S006 6/14/05 |
Zenith® AAA Endovascular Graft |
Cook Inc. Bloomington , IN 47402 |
Alternative supplier of woven polyester fabric. |
P030025/S019 6/7/05 |
TAXUS™ Express 2 Paclitaxel-Eluting Coronary Stent System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Tightening of acceptance criteria for an in-process inspection test for the matte finish length. |
P030026/S006 6/22/05 |
VITROS Immunodiagnostic Products Anti-HBc IgM Reagent Pack and Calibrators |
Ortho-Clinical Diagnostics Rochester , NY 14626 |
Addition of serum to the list of raw components. |
P040016/S001 6/7/05 |
Liberte™ Coronary Stent System |
Boston Scientific Corporation Maple Grove , MN 55311 |
Tightening of acceptance criteria for an in-process inspection test for the matte finish length. |
P040043/S005 6/14/05 |
TAG Thoracic Endoprosthesis |
W.L. Gore & Associates, Inc. Flagstaff , AZ 86001 |
Change from a manual cutting process to an automated cutting process for cuff components. |
Summary of PMA Originals & Supplements Approved
Originals: 2
Supplements: 40
Summary of PMA Originals Under Review
Total Under Review: 81
Total Active: 34
Total On Hold: 47
Number Greater Than 180 Days: 3
Summary of PMA Supplements Under Review
Total Under Review: 282
Total Active: 152
Total On Hold: 130
Number Greater Than 180 Days: 7
Summary of All PMA Submissions Received
Originals: 3
Supplements: 87
Summary of PMA Supplement PMA Approval/Denial Decision Times
Number of Approvals: 40
Number of Denials: 0
Average Days Fr Receipt to Decision (Total Time): 110.4
FDA Time: 72.1 Days MFR Time: 38.2 Days
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