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.

• Classification Name: dressing, wound and burn, interactive
• Generic Name: dressing, wound and burn, interactive
• Applicant: Organogenesis, Inc.; 150 dan road; Canton , MA 02021
• PMA Number: BP960700
• Supplement Number: S014
• Date Received: 03/01/2000
• Decision Date: 05/19/2000

• Decision: Approved
• Product Code: MGR [ Registered Establishments with MGR ]
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Normal 180 Day Track
• Expedited Review Granted?: No
• Third Party Review Elligble?: No
• Combination Product: No