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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 - TERMINALLY STERILIZED
Generic NameDevice, dermal replacement
ApplicantIntegra Lifesciences Corp.
105 Morgan Ln.
Plainsboro, NJ 08536
PMA NumberP900033
Supplement NumberS054
Date Received11/24/2015
Decision Date05/03/2016
Product Codes MDD MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a manufacturing site located at Integra LifeSciences Corporation, 109 Morgan Lane, Plainsboro, New Jersey, as a new and alternate manufacturing facility.
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