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 following four changes to the investigational plan (ip) for the postapproval study: 1) the use of additional pedicle screw spinal systems with the i/f cage component, i. E. , to allow for th euse of the ti alloy version of the vsp spine system, the ti alloy and stainless steel versions of the isola spine system, the timx spine system and the ti alloy and stainless steel versions of the moss miami spine system in addition to the stainless steel version of the vsp spine system; 2) a change in the name of the device system to be evaluated in the postapproval study to be consistent with the recently approved device system name change; 3) a modification of the intra-op case report form to allow investigators to record which pedicle screw spinal system identified in item 1 above was actually implanted; and 4) a change to the required radiographic assessment methods, i. E. , the optional use of t1-weighted mri and discography.
| 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 | 2001-03-27 |
| Decision Date | 2001-05-14 |
| PMA | P960025 |
| Supplement | S006 |
| Product Code | MCV |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| 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 |