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-L TOTAL DISC REPLACEMENT
• Generic Name: Prosthesis, intervertebral disc
• Applicant: Centinel Spine, LLC; 900 Airport Rd., Suite 3b; West Chester, PA 19380
• PMA Number: P050010
• Supplement Number: S007
• Date Received: 05/19/2010
• Decision Date: 01/14/2011
• Product Code: MJO
• Advisory Committee: Orthopedic
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR A MANUFACTURING SITE LOCATED IN WEST CHESTER, PENNSYLVANIA.