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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameSEPRAFILM(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorbalble, adhesion
ApplicantGENZYME CORP.
PMA NumberP950034
Date Received10/27/1995
Decision Date08/12/1996
Product Code
MCN[ Registered Establishments with MCN ]
Docket Number 97M-0139
Notice Date 04/16/1997
Advisory Committee General & Plastic Surgery
Expedited Review Granted? Yes
Combination Product No
Recalls CDRH 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 
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