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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameSEPRAFILM BIORESORBABLE MEMBRANE
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorbalble, adhesion
ApplicantGENZYME CORP.
PMA NumberP950034
Supplement NumberS006
Date Received06/02/1997
Decision Date06/30/1997
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - shelf-life
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a 24 month expiration date for seprafilm bioresorbable membrane.
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