PMA supplement
P220002 S001: TOPS™ System
FDA PMA supplement · Normal 180 Day Track No User Fee · Premia Spine, Ltd.
Key facts
| Original PMA | P220002 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol |
| Trade name | TOPS™ System |
| Generic name | Prosthesis, posterior spinal elements |
| Applicant | Premia Spine, Ltd. |
| Product code | QWK |
| Received date | Jul 14, 2023 |
| Decision date | Aug 11, 2023 |
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: