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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 XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEMS
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS008
Date Received06/22/1998
Decision Date07/17/1998
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 revised labeling and training materials including, the PVS Guidelines for post-procedural care and the training video entitled PVS Post Procedure Care.
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