PMA supplement
P970004 S253: InterStim® Sacral Nerve Stimulation Therapy System (Urinary Control)
FDA PMA supplement · Normal 180 Day Track No User Fee · Medtronic Neuromodulation
Key facts
| Original PMA | P970004 |
|---|---|
| Supplement number | S253 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Labeling Change - PAS |
| Trade name | InterStim® Sacral Nerve Stimulation Therapy System (Urinary Control ) |
| Generic name | Stimulator, electrical, implantable, for incontinence |
| Applicant | Medtronic Neuromodulation |
| Product code | EZW |
| Received date | Aug 21, 2017 |
| Decision date | Feb 7, 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: