Premarket Approval (PMA)

Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.

• Device: ProDisc-C Total Disc Replacement
• Generic Name: Prosthesis, intervertebral disc
• Applicant: Centinel Spine, LLC; 900 Airport Rd., Suite 3b; West Chester, PA 19380
• PMA Number: P070001
• Supplement Number: S016
• Date Received: 09/20/2017
• Decision Date: 10/20/2017
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
Change to the sealing parameters for the sterile packaging process.