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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 NameINTEGRA ARTIFICIAL SKIN, DERMAL REGENERATION TEMPLATE
Classification Namedressing, wound and burn, interactive
Generic Nameartificial skin burn wound covering
ApplicantINTEGRA
PMA NumberP900033
Supplement NumberS020
Date Received08/01/2011
Decision Date05/04/2012
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason location change: manufacturer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a manufacturing site located at integra neurosciences in anasco, puerto rico.
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