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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.
 
Device Apligraf
Classification Namecultured human cell skin dressing
Generic Namepfc
Applicant
Organogenesis, Inc.
150 dan road
Canton , MA 02021 
  
PMA NumberBP953200
Supplement NumberS092
Date Received11/14/2016
Decision Date12/13/2016
Decision 30-Day Notice - No 135-Day Supplement Needed
Product Code
PFC[ Registered Establishments with PFC ]
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
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