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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 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.
 
DeviceTECHSTAR (TM) 6 FRENCH PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
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/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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