|
Device | PRESTIGE LP Cervical Disc |
Generic Name | Prosthesis, intervertebral disc |
Applicant | Medtronic Sofamor Danek USA, Inc. 1800 Pyramid Place Memphis, TN 38132 |
PMA Number | P090029 |
Supplement Number | S009 |
Date Received | 12/11/2017 |
Decision Date | 02/13/2018 |
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 revised protocol for the post-approval study (PAS) protocol. |