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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
Classification Namebarrier, absorable, adhesion
Generic Namebarrier, absorable, adhesion
Applicant
GENZYME CORP.
55 cambridge parkway
cambridge, MA 02142
PMA NumberP950034
Supplement NumberS039
Date Received12/10/2010
Decision Date01/20/2011
Product Code
MCN[ Registered Establishments with MCN ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
QUALIFICATION OF AN ALTERNATE SUPPLIER OF RAW MATERIAL EDC.
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