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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.
 
DevicePROSTAR XL AND TECHSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS014
Date Received11/16/1998
Decision Date12/21/1998
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for adding precautions to the Clinical Procedure section of the Instructions for Use regarding suture lumen clamping.
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