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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceTRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
Generic NameDressing, wound and burn, interactive
ApplicantShire Regenerative Medicine
11095 Torreyana Rd.
San Diego, CA 92121
PMA NumberP960007
Date Received03/29/1996
Decision Date03/18/1997
Conversion Date08/14/2013
Product Code MGR 
Docket Number 98M-0993
Notice Date 12/07/1998
Advisory Committee General & Plastic Surgery
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
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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