PMA supplement
P840001 S159: RESTORE FAMILY OF NEUROSTIMULATORS
FDA PMA supplement · Normal 180 Day Track · Medtronic Neuromodulation
Key facts
| Original PMA | P840001 |
|---|---|
| Supplement number | S159 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | RESTORE FAMILY OF NEUROSTIMULATORS |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Medtronic Neuromodulation |
| Product code | LGW |
| Received date | Aug 2, 2010 |
| Decision date | Apr 22, 2011 |
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: