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 changes to osteopal's package insert.
| Device | OSTEOPAL |
| Generic Name | Bone Cement |
| Applicant | SMITH & NEPHEW RICHARDS, INC. |
| Date Received | 1998-09-14 |
| Decision Date | 1998-10-15 |
| PMA | P810020 |
| Supplement | S005 |
| Product Code | LOD |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SMITH & NEPHEW RICHARDS, INC. 1450 Brooks Rd. memphis, TN 38116 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P810020 | Original Filing | |
| S005 | 1998-09-14 | Real-time Process |
| S004 | 1995-07-20 | Normal 180 Day Track |
| S003 | 1991-11-05 | Normal 180 Day Track |
| S002 | 1988-12-12 | Normal 180 Day Track |
| S001 | 1984-06-04 |