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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.
Classification Namedressing, wound and burn, interactive
Generic Nameartificial skin burn wound covering
PMA NumberP900033
Supplement NumberS005
Date Received04/13/2001
Decision Date04/30/2001
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason labeling change - trade name
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a change in the trade name. The device will be marketed under the trade name integra(r) dermal regeneration template and is indicated for the post excisional treatment of life-threatening full-thickness or deep partial-thickness thermal injury where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient.