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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(TM)
Classification Namedressing, wound and burn, interactive
Generic Namebioengineered temporary covering
ApplicantADVANCED TISSUE SCIENCES
PMA NumberP960007
Supplement NumberS014
Date Received03/01/2000
Decision Date05/19/2000
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason location change: sterilizer
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval to conduct the final product sterility test in-house under the conditions of an isolator environment.
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