|
Device | SECURE-C CERVICAL ARTIFICIAL DISC |
Generic Name | Prosthesis, intervertebral disc |
Applicant | GLOBUS MEDICAL INC. 2560 GENERAL ARMISTEAD AVE. AUDUBON, PA 19403 |
PMA Number | P100003 |
Supplement Number | S007 |
Date Received | 12/30/2016 |
Decision Date | 08/18/2017 |
Product Code |
MJO |
Advisory Committee |
Orthopedic |
Clinical Trials | NCT00882661
|
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 seven (7) year data. |