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Device | PRODISC -L TOTAL DISC REPLACEMENT DEVICE |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Centinel Spine, LLC 900 Airport Road, 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 |
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: |
S011 S012 S013 S001 S010 S005 S006 S007 S017 S014 S016 S003 S008 S009 S002 S020 S019 S021 S022 S024 S023 |