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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 TM 8FR AND 10FR PVS AND PROSTAR XL
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS003
Date Received10/02/1997
Decision Date11/18/1997
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 changes tot he Precautions and Clinical Procedure sections of the Instructions for Use.
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