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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 OMNIGRAFT DERMAL REGENERATION MATRIX
Generic NameDressing, wound and burn, interactive
ApplicantIntegra LifeSciences Corp.
105 MORGAN LN.
PLAINSBORO, NJ 08536
PMA NumberP900033
Supplement NumberS058
Date Received11/15/2016
Decision Date01/26/2017
Product Code MGR 
Advisory Committee General & Plastic Surgery
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for a new device size (2.5cm x 2.5 cm) for both the meshed and non-meshed forms of Integra Omnigraft Dermal Regeneration Matrix.
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