This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for updated labeling to reflect seven (7) year data.
| Device | SECURE-C CERVICAL ARTIFICIAL DISC |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | GLOBUS MEDICAL INC. |
| Date Received | 2016-12-30 |
| Decision Date | 2017-08-18 |
| PMA | P100003 |
| Supplement | S007 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | GLOBUS MEDICAL INC. 2560 General Armistead Ave. audubon, PA 19403 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100003 | Original Filing | |
| S007 | 2016-12-30 | Normal 180 Day Track No User Fee |
| S006 | 2015-07-01 | Real-time Process |
| S005 | 2013-07-05 | Normal 180 Day Track |
| S004 | ||
| S003 | 2013-06-21 | Normal 180 Day Track No User Fee |
| S002 | 2013-06-06 | Real-time Process |
| S001 | 2013-02-13 | Special (immediate Track) |
| Device ID | PMA | Supp |
|---|---|---|
| 00889095154795 | P100003 | 000 |
| 00889095154948 | P100003 | 000 |
| 00889095154931 | P100003 | 000 |
| 00889095154924 | P100003 | 000 |
| 00889095154917 | P100003 | 000 |
| 00889095154900 | P100003 | 000 |
| 00889095154894 | P100003 | 000 |
| 00889095154887 | P100003 | 000 |
| 00889095154870 | P100003 | 000 |
| 00889095154863 | P100003 | 000 |
| 00889095154856 | P100003 | 000 |
| 00889095154849 | P100003 | 000 |
| 00889095154832 | P100003 | 000 |
| 00889095154825 | P100003 | 000 |
| 00889095154818 | P100003 | 000 |
| 00889095154801 | P100003 | 000 |
| 00889095154955 | P100003 | 000 |
| 00889095154962 | P100003 | 000 |
| 00889095179132 | P100003 | 000 |
| 00889095179101 | P100003 | 000 |
| 00889095179095 | P100003 | 000 |
| 00889095179064 | P100003 | 000 |
| 00889095179057 | P100003 | 000 |
| 00889095179149 | P100003 | 000 |
| 00889095179187 | P100003 | 005 |
| 00889095179194 | P100003 | 005 |
| 00889095179170 | P100003 | 005 |
| 00889095179163 | P100003 | 005 |
| 00889095179156 | P100003 | 005 |
| 00889095179125 | P100003 | 005 |
| 00889095179118 | P100003 | 005 |
| 00889095179088 | P100003 | 005 |
| 00889095179071 | P100003 | 005 |
| 00889095179200 | P100003 | 005 |