|
Device | PRODISC TM-C TOTAL DISC REPLACEMENT |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Centinel Spine, LLC 900 Airport Road, Suite 3B West Chester, PA 19380 |
PMA Number | P070001 |
Date Received | 01/03/2007 |
Decision Date | 12/17/2007 |
Product Code |
MJO |
Docket Number | 08M-0013 |
Notice Date | 01/10/2008 |
Advisory Committee |
Orthopedic |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE PRODISC-C TOTAL DISC REPLACEMENT. THE DEVICE IS INDICATED FOR SKELETALLY MATURE PATIENTS FOR RECONSTRUCTION OF THE DISC FROM C3-C7 FOLLOWING SINGLE-LEVEL DISCECTOMY FOR INTRACTABLE SYMPTOMATIC CERVICAL DISC DISEASE (SCDD). SYMPTOMATIC CERVICAL DISC DISEASE IS DEFINED AS NECK OR ARM (RADICULAR) PAIN AND/OR A FUNCTIONAL/NEUROLOGICAL DEFICIT WITH AT LEAST ONE OF THE FOLLOWING CONDITIONS CONFIRMED BY IMAGING (CT, MRI, OR X-RAYS): HERNIATED NUCLEUS PULPOSUS, SPONDYLOSIS (DEFINED BY THE PRESENCE OF OSTEOPHYTES), AND/OR LOSS OF DISC HEIGHT. THE PRODISC-C TOTAL DISC REPLACEMENT IS IMPLANTED VIA AN OPEN ANTERIOR APPROACH. PATIENTS RECEIVING THE PRODISC-C TOTAL DISC REPLACEMENT SHOULD HAVE FAILED AT LEAST SIX WEEKS OF NON-OPERATIVE TREATMENT PRIOR TO IMPLANTATION OF THE PRODISC-C TOTAL DISC REPLACEMENT. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
|
Post-Approval Study | Show Report Schedule and Study Progress |
Supplements: |
S001 S002 S004 S005 S006 S007 S008 S009 S010 S011 S012 S013 S015 S016 S017 S018 S019 S020 S021 S024 S026 S027 |