PMA supplement
P980052 S004: PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Stryker Leibinger, GmbH & Co KG
Key facts
| Original PMA | P980052 |
|---|---|
| Supplement number | S004 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | PATIENT-FITTED TMJ RECONSTRUCTION PROSTHESIS SYSTEM |
| Generic name | Joint, temporomandibular, implant |
| Applicant | Stryker Leibinger, GmbH & Co KG |
| Product code | LZD |
| Received date | Mar 3, 2009 |
| Decision date | Sep 2, 2009 |
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: