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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameTRANSCYTE "HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
Classification Namedressing, wound and burn, interactive
Generic Namebioengineered temporary covering
ApplicantSHIRE REGENERATIVE MEDICINE
PMA NumberP960007
Date Received03/29/1996
Decision Date03/18/1997
Product Code
MGR[ Registered Establishments with MGR ]
Docket Number 98M-0993
Notice Date 12/07/1998
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the dermagraft-tc(tm). The device is indicated for use as a temporary wound covering for surgically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S013 S014 S015 S016 S017 S018 S019 S020 
S021 
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