PMA supplement
P080025 S346: InterStim TM Therapy System; Verify™ Evaluation System; InterStim SNS Bowel Lead Model 978B1
FDA PMA supplement · 30-Day Notice · Medtronic Neuromodulation
Key facts
| Original PMA | P080025 |
|---|---|
| Supplement number | S346 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | InterStim TM Therapy System; Verify™ Evaluation System; InterStim SNS Bowel Lead Model 978B1 |
| Generic name | Implanted electrical device intended for treatment of fecal incontinence |
| Applicant | Medtronic Neuromodulation |
| Product code | QON |
| Received date | May 6, 2026 |
| Decision date | Jun 4, 2026 |
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: