PMA supplement
P040001 S021: X-STOP LTOS
FDA PMA supplement · Normal 180 Day Track No User Fee · Medtronic Sofamor Danek, Inc.
Key facts
| Original PMA | P040001 |
|---|---|
| Supplement number | S021 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | X-STOP LTOS |
| Generic name | Prosthesis, spinous process spacer/plate |
| Applicant | Medtronic Sofamor Danek, Inc. |
| Product code | NQO |
| Received date | Aug 5, 2013 |
| Decision date | Dec 12, 2014 |
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: