Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information. |
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Device | STARCLOSE AND STARCLOSE SE VASCULAR CLOSURE SYSTEMS |
Generic Name | Device, hemostasis, vascular |
Applicant | ABBOTT VASCULAR DEVICES 3200 LAKESIDE DRIVE SANTA CLARA, CA 95054 |
PMA Number | P050007 |
Supplement Number | S009 |
Date Received | 03/31/2008 |
Decision Date | 08/25/2008 |
Product Code |
MGB |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR MODIFICATIONS TO THE INDICATIONS FOR USE. THE DEVICE, AS MODIFIED, WILL BE INDICATED FOR THE FOLLOWING: THE PERCUTANEOUS CLOSURE OF COMMON FEMORAL ARTERY ACCESS SITES WHILE REDUCING TIMES TO HEMOSTASIS, AMBULATION, AND DISCHARGEABILITY IN PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. THE STARCLOSE VASCULAR CLOSURE SYSTEM IS INDICATED FOR USE TO ALLOW PATIENTS WHO HAVE UNDERGONE DIAGNOSTIC ENDOVASCULAR CATHETERIZATION PROCEDURES TO AMBULATE AND BE ELIGIBLE FOR DISCHARGE AS SOON AS POSSIBLE AFTER DEVICE PLACEMENT. 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 INTERVENTIONAL ENDOVASCULAR CATHETERIZATION PROCEDURES UTILIZING A 5F OR 6F PROCEDURAL SHEATH. |
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