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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
ApplicantSMITH & NEPHEW WOUND MANAGEMENT
PMA NumberP960007
Supplement NumberS017
Date Received08/22/2002
Decision Date06/28/2004
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typenormal 180 day track no user fee
Supplement Reason postapproval protocol or modification to a protocol
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for the termination of the post-approval study protocol entitle: "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. ".
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