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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(R) BIORESORBABLE MEMBRAND
Generic NameBarrier, absorbable, adhesion
ApplicantBaxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015
PMA NumberP950034
Supplement NumberS017
Date Received11/28/2000
Decision Date12/20/2000
Product Code MCN 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A NEW SIZE OF SEPRAFILM(R) AND TO CHANGE THE NAME OF THE PRODUCT FROM SEPRAFILM(R) BIORESORBABLE MEMBRANE TO SEPRAFILM(R) ADHESION BARRIER. THE LABELING HAS BEEN MODIFIED TO REFLECT THE NEW NAME AND NEW SIZE AND THE PACKAGE INSERT WAS MODIFIED TO BE INCLUDED WITH BOTH SIZES. FURTHERMORE, THE LABELING HAS BEEN MODIFIED TO OMIT THE REFERENCE TO THE CLINICAL STUDY IN THE FOREIGN BODY PRECAUTION.
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