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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.
 
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
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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