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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
Classification Namedressing, wound and burn, interactive
Generic Namebioengineered temporary covering
ApplicantADVANCED TISSUE SCIENCES
PMA NumberP960007
Supplement NumberS008
Date Received07/10/1998
Decision Date08/14/1998
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for changing the name of the product from dermagraft-tc to transcyte(tm) and for minor editoral changes to the directions for use and product label. The device, as modified, will be marketed under the trade name transcyte(tm) and is indicated for use as a temporary wound covering for sugically excised full-thickness and deep partial-thickness thermal burn wounds in patients who require such a covering prior to autograft placement; and for the treatment of mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting.
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