PMA supplement
P020016 S008: TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM
FDA PMA supplement · Normal 180 Day Track No User Fee · Biomet Microfixation, Inc.
Key facts
| Original PMA | P020016 |
|---|---|
| Supplement number | S008 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | TOTAL TEMPOROMANDIBULAR JOINT (TMJ) REPLACEMENT SYSTEM |
| Generic name | Joint, temporomandibular, implant |
| Applicant | Biomet Microfixation, Inc. |
| Product code | LZD |
| Received date | Dec 14, 2016 |
| Decision date | Jun 8, 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: