|Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.|
|Trade Name||TECHSTAR (TM) 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM|
|Applicant||ABBOTT VASCULAR INC.|
|Supplement Type||normal 180 day track|
|Supplement Reason|| change design/components/specifications/material|
|Expedited Review Granted?|| No|
|Approval Order Statement |
Approval for modified percutaneous vascular surgical devices. The devices, as modified, will be marketed under the trade names techstar(tm) 6 french percutaneous vascular surgical (pvs) system and techstar(tm) xl 6 french pvs system and are indicated for the percutaneous delivery of sutures for closing the common femoral artery access site of patients who have undergone diagnostic catheterization procedures using 5 to 6 french sheaths.