PMA supplement
P080025 S113: MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL
FDA PMA supplement · Normal 180 Day Track No User Fee · Medtronic Neuromodulation
Key facts
| Original PMA | P080025 |
|---|---|
| Supplement number | S113 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | MEDTRONIC INTERSTIM THERAPY SYSTEM FOR BOWEL |
| Generic name | Implanted electrical device intended for treatment of fecal incontinence |
| Applicant | Medtronic Neuromodulation |
| Product code | QON |
| Received date | Jun 21, 2016 |
| Decision date | Aug 24, 2016 |
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: