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 the use of the monarch spinal system to be used with the lumbar i/f cage system.
| Device | LUMBAR I/F CAGE SYSTEM |
| Classification Name | Spinal Pedicle Screw, Fixation, Appliance System |
| Generic Name | Spinal Pedicle Screw, Fixation, Appliance System |
| Applicant | DEPUY SPINE,INC |
| Date Received | 2001-12-26 |
| Decision Date | 2002-02-04 |
| PMA | P960025 |
| Supplement | S009 |
| Product Code | MCV |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | DEPUY SPINE,INC 325 Paramont Drive raynham, MA 02767 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960025 | Original Filing | |
| S011 | 2003-08-04 | Normal 180 Day Track |
| S010 | 2003-02-24 | Normal 180 Day Track |
| S009 | 2001-12-26 | Real-time Process |
| S008 | 2001-09-04 | Normal 180 Day Track |
| S007 | 2001-05-17 | Normal 180 Day Track |
| S006 | 2001-03-27 | Normal 180 Day Track |
| S005 | 2000-06-06 | Normal 180 Day Track |
| S004 | 2000-04-06 | Real-time Process |
| S003 | 2000-03-23 | Real-time Process |
| S002 | 2000-03-06 | Normal 180 Day Track |
| S001 | 1999-06-07 | Normal 180 Day Track No User Fee |