Premarket Approval (PMA)

Note: this medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.

• Device: PRODISC -L TOTAL DISC REPLACEMENT DEVICE
• Generic Name: Prosthesis, intervertebral disc
• Applicant: Centinel Spine, LLC; 900 Airport Rd., Suite 3b; West Chester, PA 19380
• PMA Number: P050010
• Date Received: 03/15/2005
• Decision Date: 08/14/2006
• Product Code: MJO
• Docket Number: 06M-0343
• Notice Date: 08/25/2006
• Advisory Committee: Orthopedic
• Expedited Review Granted?: No
• Combination Product: No
• Predetermined Change Control Plan Authorized: No

Approval Order Statement  
APPROVAL FOR THE PRODISC-L TOTAL DISC REPLACEMENT. THE DEVICE IS INDICATED FOR SPINAL ARTHROPLASTY IN SKELETALLY MATURE PATIENTS WITH DEGENERATIVE DISC DISEASE (DDD) AT ONE LEVEL FROM L3-S1. DDD IS DEFINED AS DISCOGENIC BACK PAIN WITH DEGENERATION OF THE DISC CONFIRMED BY PATIENT HISTORY AND RADIOGRAPHIC STUDIES. THESE DDD PATIENTS SHOULD HAVE NO MORE THAN GRADE 1 SPONDYLOLISTHESIS AT THE INVOLVED LEVEL. PATIENTS RECEIVING THE PRODISC-L TOTAL DISC REPLACEMENT SHOULD HAVE FAILED AT LEAST SIX MONTHS OF CONSERVATIVE TREATMENT PRIOR TO IMPLANTATION OF THE PRODISC-L TOTAL DISC REPLACEMENT.

• Approval Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Supplements: S001 S002 S003 S005 S006 S007 S008 S009 S010 S011 S012 ; S013 S014 S016 S017 S019 S020 S021 S022 S023 S024 S025 S026 ; S027 S028