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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
Classification Namedressing, wound and burn, interactive
Generic Nameartificial skin burn wound covering
ApplicantINTEGRA LIFESCIENCES CORP.
PMA NumberP900033
Supplement NumberS008
Date Received10/26/2001
Decision Date04/19/2002
Product Code
MGR[ Registered Establishments with MGR ]
Docket Number 02M-0216
Notice Date 05/13/2002
Advisory Committee General & Plastic Surgery
Supplement Typepanel track
Supplement Reason labeling change - indications
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the integra dermal regeneration template. This device is indicated for "the postexcisional treatment of life-threatening full-thickness or deep partial-thickness thermal injuries where sufficient autograft is not available at the time of excision or not desirable due to the physiological condition of the patient. Integra dermal regeneration template 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. ".
Approval Order Approval Order
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