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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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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 NameTECHSTAR (TM) 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
ApplicantABBOTT VASCULAR INC.
PMA NumberP960043
Supplement NumberS001
Date Received05/01/1997
Decision Date11/05/1997
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product 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.
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