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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, and Integra Omnigraft Dermal Regenera
Generic NameDressing, wound and burn, interactive
ApplicantIntegra Lifesciences Corp.
105 Morgan Ln.
Plainsboro, NJ 08536
PMA NumberP900033
Supplement NumberS090
Date Received09/17/2020
Decision Date10/13/2020
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  
Modification of steam sterilization load patterns for the Getinge Autoclave at the Integra Life Sciences facility in Plainsboro, New Jersey.
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