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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 andIntegra Omnigraft Dermal Regenerati
Generic NameDressing, wound and burn, interactive
ApplicantIntegra LifeSciences Corp.
105 MORGAN LN.
PLAINSBORO, NJ 08536
PMA NumberP900033
Supplement NumberS066
Date Received10/30/2017
Decision Date11/28/2017
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
Approval Order Statement  
Qualification of a second Electron Beam for the sterilization of Collagen Glycosaminoglycan (GAG) Matrix products at Steris Applied Sterilization Technologies' Saxonburg, Pennsylvania facility.
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