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 clarifying the worst-case temperature rise for the subject device and revising the labeling to adequately reflect those temperature. The secure-c cervical artificial disc can be now be labeled as mr compatible.
| Device | SECURE -C CERVICAL ARTIFICIAL DISC |
| Generic Name | Prosthesis, Intervertebral Disc |
| Applicant | GLOBUS MEDICAL INC. |
| Date Received | 2015-07-01 |
| Decision Date | 2016-05-17 |
| PMA | P100003 |
| Supplement | S006 |
| Product Code | MJO |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| 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 |