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.
| Device | SURGICAL SIMPLEX(R) P BONE CEMENT |
| Generic Name | Bone Cement |
| Applicant | HOWMEDICA CORP. |
| Date Received | 1991-10-08 |
| Decision Date | 1992-10-01 |
| PMA | N17003 |
| Supplement | S003 |
| Product Code | LOD |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOWMEDICA CORP. 359 Veterans Blvd. rutherford, NJ 07070 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| N17003 | Original Filing | |
| S004 | 1993-05-21 | Normal 180 Day Track |
| S003 | 1991-10-08 | Normal 180 Day Track |
| S002 | 1990-04-30 | Normal 180 Day Track |
| S001 | 1981-03-03 | Normal 180 Day Track |