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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 AND CLOSURE SUTURE-MEDIATED CLOSURE SYSTEMS
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS037
Date Received01/14/2002
Decision Date02/13/2002
Product Code MGB 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
RECLASSIFICATION OF THE CLEANROOM FROM CLASS 10,000 OF THE FEDERAL STANDARD 209E TO CLASS 8 OF ISO 14644-1 USED IN THE MANUFACTURE OF THE PROSTAR AND CLOSURE SUTURE-MEDIATED CLOSURE SYSTEMS.
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