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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 ARTIFICIAL SKIN DERMAL REGENERATION TEMPLATE
Generic NameDevice, dermal replacement
ApplicantIntegra Lifesciences Corp.
105 Morgan Ln.
Plainsboro, NJ 08536
PMA NumberP900033
Supplement NumberS043
Date Received02/03/2015
Decision Date03/04/2015
Product Codes MDD MGR 
Advisory Committee General & Plastic Surgery
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
QUALIFICATION OF A NEW PRODUCT PACKAGE SEALING EQUIPMENT FOR THE INTEGRA DERMAL REGENERATION TEMPLATE, AT THE PLAINSBORO, NEW JERSEY, INTEGRA MANUFACTURING FACILITY.
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