PMA supplement
P000035 S010: TMJ FOSSA-EMIENCE PROSTHESIS SYSTEM
FDA PMA supplement · 30-Day Notice · Nexus CMF, LLC
Key facts
| Original PMA | P000035 |
|---|---|
| Supplement number | S010 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | TMJ FOSSA-EMIENCE PROSTHESIS SYSTEM |
| Generic name | Glenoid fossa prosthesis |
| Applicant | Nexus CMF, LLC |
| Product code | MPI |
| Received date | May 2, 2014 |
| Decision date | May 21, 2014 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: