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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceSEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
Generic NameBarrier, absorbable, adhesion
ApplicantBaxter Healthcare Corporation
One Baxter Parkway
Deerfield, IL 60015
PMA NumberP950034
Date Received10/27/1995
Decision Date08/12/1996
Product Code MCN 
Docket Number 97M-0139
Notice Date 04/16/1997
Advisory Committee General & Plastic Surgery
Expedited Review Granted? Yes
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE SEPRAFILM BIORESORBABLE MEMBRANE
Supplements:  S001 S002 S003 S005 S006 S007 S008 S010 S011 S012 S013 
S014 S015 S016 S017 S018 S020 S021 S022 S023 S024 S025 S026 
S027 S028 S031 S032 S033 S034 S035 S036 S037 S038 S039 S040 
S041 S042 S043 S044 S045 S046 S047 S048 S049 S050 S052 S053 
S055 
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