PMA supplement
P970004 S319: InterStim Therapy System and Verify Evaluation System (SNS Urinary)
FDA PMA supplement · 30-Day Notice · Medtronic Neuromodulation
Key facts
| Original PMA | P970004 |
|---|---|
| Supplement number | S319 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | InterStim Therapy System and Verify Evaluation System (SNS Urinary) |
| Generic name | Stimulator, electrical, implantable, for incontinence |
| Applicant | Medtronic Neuromodulation |
| Product code | EZW |
| Received date | Oct 15, 2020 |
| Decision date | Nov 12, 2020 |
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: