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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Device Dermagraft-TC (temporary covering)
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
Organogenesis, Inc.
150 dan road
Canton , MA 02021 
  
PMA NumberBP960700
Date Received03/29/1996
Decision Date03/18/1997
Decision Approved
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S013 S014 S015 S016 S017 S018 S019 S020 
S021 S027 S028 S034 S036 S037 
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