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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-TC(TM)
Classification Namedressing, wound and burn, interactive
Generic Namebioengineered temporary covering
ApplicantADVANCED TISSUE SCIENCES
PMA NumberP960007
Supplement NumberS002
Date Received05/05/1997
Decision Date05/29/1998
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a post approval study assessing the incidence of burn wound infection in in patients who require a temporary wound covering, dermagraft-tc, for surgically excised full-thickness and deep-partial thickness thermal burn wounds in patients who require sucha covering prior to autograft placement.
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