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: ALVEOFORM TM BIOGRAFT
• Classification Name: bone grafting material, animal source
• Generic Name: oral grafting implant
• Regulation Number: 872.3930
• Applicant: COLLAGEN CORP.
• PMA Number: P860012
• Supplement Number: S004
• Date Received: 08/31/1990
• Decision Date: 09/12/1990
• Product Code: NPM [ Registered Establishments with NPM ]
• Advisory Committee: Orthopedic
• Supplement Type: Special Supplement
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No