PMA supplement
P840001 S469: Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems, Pisces, Specify and Vectris Spinal Cord St
FDA PMA supplement · Panel Track · Medtronic Neuromodulation
Key facts
| Original PMA | P840001 |
|---|---|
| Supplement number | S469 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | Restore, Itrel, Synergy, Intellis, and Vanta Spinal Cord Stimulation Systems, Pisces, Specify and Vectris Spinal Cord St |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Medtronic Neuromodulation |
| Product code | LGW |
| Received date | Aug 10, 2021 |
| Decision date | Jan 21, 2022 |
| Docket number | 22M-0089 |
| Notice date | Jan 25, 2022 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: