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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 8 AND 10 FRENCH, CLOSER, CLOSER S, PERCLOSE AT, AND PERCLOSE AT MONOFILAMENT 6 FRENCH SUTURE MEDIATED CLOSER
Generic NameDevice, hemostasis, vascular
ApplicantAbbott Vascular, Inc.
400 Saginaw Dr.
Redwood, CA 94063
PMA NumberP960043
Supplement NumberS047
Date Received07/08/2003
Decision Date09/02/2003
Product Code MGB 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL TO ADD WORDING IN THE PRECAUTIONS SECTION IN THE LABELING, INFORMING THE USER THAT REACCESS/REPUNCTURE OF THE FEMORAL ARTERY WITH THE ABOVE LISTED DEVICES IS NOT RESTRICTED FOR PATIENTS WHO HAVE PREVIOUSLY RECEIVED THESE DEVICES IN EARLIER ARTERIOTOMY REPAIRS.
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