|
Device | Prestige LP Cervical Disc – Two Level |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P090029 |
Supplement Number | S012 |
Date Received | 05/23/2019 |
Decision Date | 07/12/2019 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT03062657
|
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Postapproval Study Protocol |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval of the revised protocol for the post-approval study (PAS) protocol. |