PMA
P000035: TMJ FOSSA-EMINENCE PROSTHESIS(TM)
FDA PMA · Glenoid fossa prosthesis · Nexus CMF, LLC
Key facts
| PMA number | P000035 |
|---|---|
| Trade name | TMJ FOSSA-EMINENCE PROSTHESIS(TM) |
| Generic name | Glenoid fossa prosthesis |
| Applicant | Nexus CMF, LLC |
| Owner/operator | Nexus CMF |
| Product code | MPI |
| Approval date | Feb 27, 2001 |
| Docket number | 01M-0210 |
| Notice date | May 14, 2001 |
| Establishment registration | 3009702671 |
| FEI number | 3009702671 |
At a glance
- 10–99 Supplements
- Feb 13, 2015 Latest supplement decision
- No Withdrawn
- Yes 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: