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: PRODISC -C TOTAL DISC REPLACEMENT
• Classification Name: prosthesis, intervertebral disc
• Applicant: SYNTHES SPINE
• PMA Number: P070001
• Supplement Number: S009
• Date Received: 08/10/2010
• Decision Date: 02/16/2011
• Product Code: MJO [ Registered Establishments with MJO ]
• Advisory Committee: Orthopedic
• Supplement Type: real-time process
• Supplement Reason: labeling change - instructions
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for mr conditional labeling.