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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, INTEGRA MESHED DERMAL REGENERATION TEMPLATE
Generic NameDevice, dermal replacement
ApplicantIntegra Lifesciences Corp.
105 Morgan Ln.
Plainsboro, NJ 08536
PMA NumberP900033
Supplement NumberS047
Date Received05/20/2015
Decision Date08/06/2015
Product Codes MDD MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR ADDING TWO NEW SIZE OFFERINGS: 4CM X 4CM AND 7CM X 7CM.
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