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: S045
• Date Received: 10/29/2007
• Decision Date: 08/17/2010
• Product Code: MGR [ Registered Establishments with MGR ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: real-time process
• Supplement Reason: labeling change - minor
• Expedited Review Granted?: No
• Combination Product: Yes

Approval Order Statement 
Approval for revisions to the diabetic foot ulcer and venous leg ulcer patient brochures.