|
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 | S017 |
Date Received | 12/04/2018 |
Decision Date | 05/31/2019 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00291018
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - Indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for updated labeling to reflect the Post Approval Study Protocol. |