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 changing the volume of material used in the post-approval rabbit study.
| Device | NORIAN SRS BONE CEMENT |
| Classification Name | Bone Cement |
| Generic Name | Bone Cement |
| Applicant | SYNTHES (USA) |
| Date Received | 2000-06-06 |
| Decision Date | 2000-08-31 |
| PMA | P970010 |
| Supplement | S004 |
| Product Code | LOD |
| Advisory Committee | Physical Medicine |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SYNTHES (USA) 1690 Russell Rd. post Office Box 1766 paoli, PA 19301 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P970010 | Original Filing | |
| S004 | 2000-06-06 | Normal 180 Day Track |
| S003 | ||
| S002 | 2000-03-02 | Normal 180 Day Track |
| S001 | 1999-02-08 | Normal 180 Day Track |