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 another sterilization site located at sterigenics international, 3125 wichita court, forth worth, texas 76140.
| Device | NATURAL-KNEE(R) WITH CSTI(TM) |
| 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 | 1997-06-17 |
| Decision Date | 1997-10-16 |
| PMA | P940002 |
| Supplement | S002 |
| Product Code | MBD |
| 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 | 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 |