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: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
• Classification Name: joint, temporomandibular, implant
• Generic Name: total temporomandibular joint prosthesis
• Regulation Number: 872.3940
• Applicant: TMJ CONCEPTS
• PMA Number: P980052
• Supplement Number: S004
• Date Received: 03/03/2009
• Decision Date: 09/02/2009
• Product Code: LZD [ Registered Establishments with LZD ]
• Advisory Committee: Dental
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: labeling change - other
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for modified labeling.