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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, Intergra Meshed Dermal Regeneration Template, and Integra Omnigraft Dermal Regener
Generic NameDressing, wound and burn, interactive
ApplicantIntegra Lifesciences Corp.
105 Morgan Ln.
Plainsboro, NJ 08536
PMA NumberP900033
Supplement NumberS079
Date Received04/08/2019
Decision Date05/07/2019
Product Code 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  
Delete select surface contact sites from Routine Environmental Monitoring for the following rooms: CMC-105 and CMC-109 at the Integra LifeSciences Corporation, Collagen Manufacturing Center in Plainsboro, New Jersey.
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