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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceINTEGRA DERMAL REGENERATION TEMPLATE
Generic NameDevice, dermal replacement
ApplicantIntegra LifeSciences Corp.
105 MORGAN LN.
PLAINSBORO, NJ 08536
PMA NumberP900033
Supplement NumberS008
Date Received10/26/2001
Decision Date04/19/2002
Product Codes MDD MGR 
Docket Number 02M-0216
Notice Date 05/13/2002
Advisory Committee General & Plastic Surgery
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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