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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 NumberS015
Date Received06/26/2001
Decision Date08/30/2001
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for amended labeling to include information regarding the results of testing the donor mother's sera for viruses and other infectious agents.
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