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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 NameINTEGRA DERMAL REGENERATION TEMPLATE, INTEGRA MESHED DERMAL REGENERATION TEMPLATE
Classification Namedressing, wound and burn, interactive
Generic Nameartificial skin burn wound covering
ApplicantINTEGRA LIFESCIENCES
PMA NumberP900033
Supplement NumberS033
Date Received01/07/2014
Decision Date04/07/2014
Product Code
MGR[ Registered Establishments with MGR ]
Advisory Committee General & Plastic Surgery
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for a design change to the integra® dermal regeneration template. The design change was to produce a meshed version of the integra® dermal regeneration template. The device, as modified, will be marketed under the trade name integra® meshed dermal regeneration template and is indicated for the post excisional treatment of life-threatening full-thickness or deep partial thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. It is also indicated for the repair of scar contractures when other therapies have failed or when donor sites for repair are not sufficient or desirable due to the physiological condition of the patient.
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