PMA
P940002: NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM)
FDA PMA · PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER · Sulzermedica
Key facts
| PMA number | P940002 |
|---|---|
| Trade name | NATURAL-KNEE(R) AND NATURAL KNEE(R)II W/CSTI(TM) |
| Generic name | PROSTHESIS, KNEE, PATELLO/FEMOROTIBIAL, UNCONSTRAINED, UNCEMENTED, POROUS, COATED, POLYMER/METAL/POLYMER |
| Applicant | Sulzermedica |
| Product code | MBD |
| Approval date | Mar 21, 1997 |
| Docket number | 97M-0252 |
| Notice date | Jun 30, 1997 |
At a glance
- 1–9 Supplements
- Aug 1, 2001 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: