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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.
 
DeviceSEPRAFILM BIORESORBABLE MEMBRANE
Generic NameBarrier, absorbable, adhesion
ApplicantBaxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake, IL 60015
PMA NumberP950034
Supplement NumberS008
Date Received01/28/1998
Decision Date08/18/1998
Product Code MCN 
Advisory Committee General & Plastic Surgery
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 for the extension of the expiration dating period for Seprafilm(R) Bioresorbable membrane from 24 monts to 30 months.
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