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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.
 
DeviceTRANSCYTE HUMAN FIBROBLAST-DERIVED TEMPORARY SKIN SUBSTITUTE
Classification Namedressing, wound and burn, interactive
Generic Namedressing, wound and burn, interactive
Applicant
SHIRE REGENERATIVE MEDICINE
11095 torreyana road
san diego, CA 92121
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 study protocol - ode/oir
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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