|
Device | PRODISC 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 |
Supplement Number | S002 |
Date Received | 03/12/2008 |
Decision Date | 08/11/2008 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol - OSB |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL OF THE POST-APPROVAL STUDY. |