Premarket Approval (PMA)

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.

• Device: ALVEOFORM TM BIOGRAFT
• Generic Name: BONE GRAFTING MATERIAL, ANIMAL SOURCE
• Regulation Number: 872.3930
• Applicant: Collagen Corp.; 2500 Faber Pl.; Palo Alto, CA 94303
• PMA Number: P860012
• Supplement Number: S004
• Date Received: 08/31/1990
• Decision Date: 09/12/1990
• Reclassified Date: 05/31/2005
• Product Code: NPM
• Advisory Committee: General & Plastic Surgery
• Supplement Type: Special (Immediate Track)
• Supplement Reason: Labeling Change - Indications/instructions/shelf life/tradename
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No