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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
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 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 study protocol - ode/oir
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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