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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 NumberS013
Date Received08/09/1999
Decision Date09/03/1999
Product Code MCN 
Advisory Committee General & Plastic Surgery
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  
The 30-Day Notice requested a manufacturing process change for Seprafilm(R) Bioresorbable Membrane. The requested change would allow the use of a new Urania Heat Sealer, Model 3500-P, to seal the foil pouches containing Seprafilm(R).
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