PMA supplement
P840001 S377: Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S
FDA PMA supplement · Normal 180 Day Track No User Fee · Medtronic Neuromodulation
Key facts
| Original PMA | P840001 |
|---|---|
| Supplement number | S377 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Master Restore, Itrel, Synergy and Intellis Spinal Cord Stimulation Systems and Pisces Specify and Vectris Spinal Cord S |
| Generic name | Stimulator, spinal-cord, totally implanted for pain relief |
| Applicant | Medtronic Neuromodulation |
| Product code | LGW |
| Received date | Sep 5, 2017 |
| Decision date | Apr 13, 2018 |
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: