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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(TM) (HAL-F(TM)) BIORESORBABLE MEMBRANE
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorbalble, adhesion
ApplicantGENZYME CORP.
PMA NumberP950034
Supplement NumberS001
Date Received10/22/1996
Decision Date11/07/1996
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the current ha/cmc specification for the urea assay from the current 3 - 15% to a specification of 10-18% for the modified assay. The supplement also requests the replacement of the usp rabbit pyrogen assay with the limulus amoebocyte lysate (lal) assay as the standard pyrogen test.
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