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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 Rd.
San Diego, CA 92121
PMA NumberP960007
Supplement NumberS017
Date Received08/22/2002
Decision Date06/28/2004
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE TERMINATION OF THE POST-APPROVAL STUDY PROTOCOL ENTITLE: "A RANDOMIZED, CONTROLLED WITHIN-PATIENT-PAIRED STUDY TO COMPARE THE EFFECTIVENESS OF TRANSCYTE AND BIOBRANE IN THE TREATMENT OF MID-DERMAL TO INDETERMINATE DEPTH BURN WOUNDS."
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