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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceTRANSCYTE
Generic NameDressing, wound and burn, interactive
ApplicantSHIRE REGENERATIVE MEDICINE
11095 TORREYANA ROAD
SAN DIEGO, CA 92121
PMA NumberP960007
Supplement NumberS008
Date Received07/10/1998
Decision Date08/14/1998
Conversion Date 08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for changing the name of the product from Dermagraft-TC to TransCyte(TM) and for minor editoral changes to the Directions for Use and product label. The device, as modified, will be marketed under the trade name TransCyte(TM) and is indicated for use as a temporary wound covering for sugically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement; and for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.
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