|
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 | S011 |
Date Received | 10/31/2018 |
Decision Date | 04/26/2019 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Supplement Type | Normal 180 Day Track No User Fee |
Supplement Reason | Labeling Change - PAS |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for labeling updated to include post-approval study results from the continued follow-up of the IDE cohort. |