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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 NumberS005
Date Received04/16/1997
Decision Date02/25/1998
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
In this supplment the applicant agrees to submit an investigational device exemptions (ide) application for the modified postapproval safety study, is approved. We believe that this study, with the modifications as discussed, will satisfy the condition ofapproval for this pma, but we may have additional comments on the ide botha s it related to the objectives of the postapproval study, depending on your responses, and your objective of collecting outcomes data on the incidence of small bowel obstruction.
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