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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 (DERMAGRAFT-TC)
Generic NameDressing, wound and burn, interactive
ApplicantShire Regenerative Medicine
11095 Torreyana Rd.
San Diego, CA 92121
PMA NumberP960007
Supplement NumberS009
Date Received07/24/1998
Decision Date12/01/1998
Conversion Date08/14/2013
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval that the ATP assay be used in place of the MTT assay as a means of monitoring and predicting product characteristics. The product release criteria of the ATP assay stipulate that production lots of TransCyte will be harvested between incubation days 12 to 16 and must have an ATP value in the range of 0.083 to 0.127 moles per bioreactor to be considered an acceptable lot.
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