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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 BIOHEALING, INC
PMA NumberP960007
Supplement NumberS020
Date Received11/01/2010
Decision Date06/13/2011
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of the automated and manual cell expansion trypsinization processes for manufacturing transcyte.
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