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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
Classification Namedevice, hemostasis, vascular
Generic Namedevice, hemostasis, vascular
Applicant
ABBOTT VASCULAR INC.
400 saginaw drive
redwood city, CA 94063
PMA NumberP960043
Supplement NumberS047
Date Received07/08/2003
Decision Date09/02/2003
Product Code
MGB[ Registered Establishments with MGB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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