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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 NumberS016
Date Received05/30/2000
Decision Date07/07/2000
Product Code MCN 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Other
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ELIMINATION OF THE RAT CECAL ABRASION BIOASSAY AS A FINISHED PRODUCT RELEASE CRITERION AND AS A STABILITY TEST.
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