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 in the manufacturing process to further assure the cleanliness of the devices.
| Device | NATURAL-KNEE AND NATURAL-KNEE II |
| Classification Name | Prosthesis, Knee, Patello/femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Generic Name | Prosthesis, Knee, Patello/femorotibial, Unconstrained, Uncemented, Porous, Coated, Polymer/metal/polymer |
| Applicant | SULZERMEDICA |
| Date Received | 2001-07-12 |
| Decision Date | 2001-08-01 |
| PMA | P940002 |
| Supplement | S005 |
| Product Code | MBD |
| Advisory Committee | Orthopedic |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | SULZERMEDICA 9900 Spectrum Dr. austin,, TX 78717 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P940002 | Original Filing | |
| S005 | 2001-07-12 | Special (immediate Track) |
| S004 | ||
| S003 | 2000-03-24 | Special (immediate Track) |
| S002 | 1997-06-17 | Normal 180 Day Track |
| S001 | 1997-04-02 | Real-time Process |