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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 ADHESION BARRIER
Generic NameBarrier, absorbable, adhesion
ApplicantBaxter Healthcare Corporation
One Baxter Pkwy.
Deerfield Lake, IL 60015
PMA NumberP950034
Supplement NumberS043
Date Received10/29/2015
Decision Date12/03/2015
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  
A CHANGE IN THE SOFTWARE USED TO MANAGE AND PRINT BARCODES AND LABELS FOR THE SEPRAFILM ADHESION BARRIER DEVICE.
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