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 | BIAS(R) FIBER METAL TOTAL HIP SYSTEM |
| Generic Name | Prosthesis, Hip, Semi-constrained, Metal/polymer, Porous Uncemented |
| Applicant | ZIMMER, INC. |
| Date Received | 1990-08-13 |
| Decision Date | 1991-03-08 |
| PMA | P850061 |
| Supplement | S002 |
| Product Code | LPH |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Other Report |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ZIMMER, INC. po Box 708 warsaw, IN 46580-0708 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P850061 | Original Filing | |
| S002 | 1990-08-13 | Normal 180 Day Track |
| S001 | 1989-02-08 | Normal 180 Day Track |