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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(R) BIORESORBABLE MEMBRAND
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorbalble, adhesion
ApplicantGENZYME CORP.
PMA NumberP950034
Supplement NumberS017
Date Received11/28/2000
Decision Date12/20/2000
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a new size of seprafilm(r) and to change the name of the product from seprafilm(r) bioresorbable membrane to seprafilm(r) adhesion barrier. The labeling has been modified to reflect the new name and new size and the package insert was modified to be included with both sizes. Furthermore, the labeling has been modified to omit the reference to the clinical study in the foreign body precaution.
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