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: S004
• Date Received: 05/19/2010
• Decision Date: 01/14/2011
• Product Code: MJO [ Registered Establishments with MJO ]
• Advisory Committee: Orthopedic
• Supplement Type: normal 180 day track no user fee
• Supplement Reason: location change: packager
• Expedited Review Granted?: No
• Combination Product: No

Approval Order Statement 
Approval for a manufacturing site located in west chester, pennsylvania.