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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 NumberS012
Date Received08/03/1999
Decision Date08/27/1999
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
The 30-day notice requested a manufacturing process change for seprafilm(r) bioresorbable membrane. The requested change would allow the use of labelmax software and high speed laser printers to print the entire seprafilm(r) pouch front label and a new 10 pack box/envelop carton label.
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