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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 supplement. The device description may have changed. Be sure to look at the original PMA 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
ApplicantADVANCED TISSUE SCIENCES
PMA NumberP960007
Supplement NumberS016
Date Received11/05/2001
Decision Date12/26/2001
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the ceasing of enrollment of new patients in the post-market approval study: tc-01-07-0597 "an open label study to evaluate the incidence of wound infection in patients requiring a temporary covering for excised burn wounds".
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