Premarket Approval (PMA)

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
• Classification Name: dressing, wound and burn, interactive
• Generic Name: graftskin
• Applicant: ORGANOGENESIS, INC.
• PMA Number: P950032
• Supplement Number: S065
• Date Received: 10/27/2011
• Decision Date: 11/22/2011
• Product Code: MGR [ Registered Establishments with MGR ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: 30-day notice
• Supplement Reason: process change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Implementation of an alternate vendor.