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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 BIORESORBABLE MEMBRANE
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorable, adhesion
Applicant
GENZYME CORP.
55 cambridge parkway
cambridge, MA 02142
PMA NumberP950034
Supplement NumberS016
Date Received05/30/2000
Decision Date07/07/2000
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason other report
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
APPROVAL FOR ELIMINATION OF THE RAT CECAL ABRASION BIOASSAY AS A FINISHED PRODUCT RELEASE CRITERION AND AS A STABILITY TEST.
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