PMA - Premarket Approval

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New Search Back to Search Results Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.   Trade Name APLIGRAF (GRAFTSKIN) Classification Name dressing, wound and burn, interactive Generic Name graftskin Applicant ORGANOGENESIS, INC. PMA Number P950032 Supplement Number S026 Date Received 08/15/2001 Decision Date 09/14/2001 Product Code MGR [ Registered Establishments with MGR ] Advisory Committee General & Plastic Surgery Supplement Type 30-day notice Supplement Reason process change: manufacturing Expedited Review Granted? No Approval Order Statement  Modification to the shipper box to now contain 12 pounds of eutectic bricks to maintain temperatures above 20 degrees celcius for the 72 hour duration.