PMA supplement
P980052 S011: TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis
FDA PMA supplement · 30-Day Notice · Stryker Leibinger, GmbH & Co KG
Key facts
| Original PMA | P980052 |
|---|---|
| Supplement number | S011 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | TMJ Concepts Patient-Fitted TMJ Reconstruction Prosthesis |
| Generic name | Joint, temporomandibular, implant |
| Applicant | Stryker Leibinger, GmbH & Co KG |
| Product code | LZD |
| Received date | Aug 22, 2022 |
| Decision date | Aug 31, 2022 |
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: