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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
Classification Namedressing, wound and burn, interactive
ApplicantSHIRE REGENERATIVE MEDICINE
PMA NumberP000036
Supplement NumberS016
Date Received04/23/2013
Decision Date05/21/2013
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Change in the software used to regulate the dermagraft cell culture process.
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