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.
Approvla for postapproval protocol and modifications to your package inserts
| 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 | 1997-04-02 |
| Decision Date | 1997-04-30 |
| PMA | P940002 |
| Supplement | S001 |
| Product Code | MBD |
| Advisory Committee | Orthopedic |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |