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 post-approval clinical and animal study protocols that were requested as conditions of approval for the pma.
| Device | NORIAN SRS CEMENT |
| Generic Name | Bone Cement |
| Applicant | SYNTHES (USA) |
| Date Received | 1999-02-08 |
| Decision Date | 1999-07-16 |
| PMA | P970010 |
| Supplement | S001 |
| 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 |