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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 NameDERMAGRAFT HUMAN FIBROBLAST-DERIVED DERMAL SUBSTITUTE
Classification Namedressing, wound and burn, interactive
ApplicantADVANCED BIOHEALING, INC
PMA NumberP000036
Supplement NumberS013
Date Received06/29/2012
Decision Date07/23/2012
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Usage of two additional vacuum sealers during the packaging process.
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