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Device | STARCLOSE VASCULAR CLOSURE SYSTEM |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR DEVICES 3200 LAKESIDE DRIVE SANTA CLARA, CA 95054 |
PMA Number | P050007 |
Supplement Number | S001 |
Date Received | 12/27/2005 |
Decision Date | 02/02/2007 |
Product Code |
MGB |
Docket Number | 07M-0058 |
Notice Date | 02/21/2007 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE STARCLOSE VASCULAR CLOSURE SYSTEM. THIS DEVICE IS INDICATED AS FOLLOWS:THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS AND AMBULATION, IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC OR INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH.THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIME TO DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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