PMA supplement
P010014 S068: Oxford Partial Knee System - Femoral and Tibial Tray Components
FDA PMA supplement · Special (Immediate Track) · Biomet Manufacturing Corp
Key facts
| Original PMA | P010014 |
|---|---|
| Supplement number | S068 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Oxford Partial Knee System - Femoral and Tibial Tray Components |
| Generic name | Prosthesis, knee, femorotibial, unicompartmental, semi-constrained, metal/polymer, mobile bearing |
| Applicant | Biomet Manufacturing Corp |
| Product code | NRA |
| Received date | Nov 16, 2017 |
| Decision date | Dec 13, 2017 |
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: