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 | P.C.A.(TM) TOTAL KNEE SYSTEM |
| Generic Name | Prosthesis, Knee, Femorotibial, Semi-constrained, Cemented, Metal/polymer |
| Applicant | HOWMEDICA CORP. |
| Date Received | 1989-05-03 |
| Decision Date | 1991-09-10 |
| PMA | P840049 |
| Supplement | S001 |
| Product Code | HRY |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | HOWMEDICA CORP. 359 Veterans Blvd. rutherford, NJ 07070 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P840049 | Original Filing | |
| S001 | 1989-05-03 | Normal 180 Day Track |