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: S002
• Date Received: 03/12/2008
• Decision Date: 08/11/2008
• Product Code: MJO [ Registered Establishments with MJO ]
• Advisory Committee: Orthopedic
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: postapproval protocol or modification to a protocol
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval of the post-approval study.