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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
Generic NameBarrier, absorbable, adhesion
ApplicantBaxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015
PMA NumberP950034
Supplement NumberS036
Date Received10/08/2010
Decision Date12/02/2010
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
Approval Order Statement  
UPGRADES MADE IN MANUFACTURING AREAS AND EQUIPMENT.
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