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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 NameDERMAGRAFT-TC(TM)
Classification Namedressing, wound and burn, interactive
Generic Namebioengineered temporary covering
ApplicantADVANCED TISSUE SCIENCES
PMA NumberP960007
Supplement NumberS006
Date Received11/24/1997
Decision Date08/05/1999
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track
Supplement Reason other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for "a randomized, controlled, within-patient-paired study to compare the effectiveness of transcyte and biobrane in the treatment of mid-dermal to indeterminate depth burn wounds. " this study addresses one of the conditions of approval in the october 17, 1997 agency letter for the indication of partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. The condition was for a postapproval protocol for a multi-center study utilizing a within patient comparison of dermagraft-tc (transcyte) to a control treatment for partial thickness burns that are mid-dermal to indeterminate depth burn wounds that typically require debridement and that may be expected to heal without autografting. Included in this submission was to be a sample size justification for the number of patients to be evaluated. The endpoints of this study were also to include evaluation of infection rates and rate of patients who go on to require autografting.
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