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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
Classification Namecultured human cell skin dressing
Generic Namepfc
Applicant
Organogenesis, Inc.
150 dan road
Canton , MA 02021 
  
PMA NumberBP003600
Date Received08/25/2000
Decision Date09/28/2001
Decision Approved
Product Code
PFC[ Registered Establishments with PFC ]
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
Supplements: S002 S003 S006 S007 S008 S009 S010 S011 S012 
S013 S014 S016 S017 S018 S019 S023 S027 S028 
S029 S030 S032 S033 S034 S036 S040 S042 S045 
S046 S047 
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