PMA supplement
P080025 S116: MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM FOR BOWEL
FDA PMA supplement · Special (Immediate Track) · Medtronic Neuromodulation
Key facts
| Original PMA | P080025 |
|---|---|
| Supplement number | S116 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM FOR BOWEL |
| Generic name | Implanted electrical device intended for treatment of fecal incontinence |
| Applicant | Medtronic Neuromodulation |
| Product code | QON |
| Received date | Jul 8, 2016 |
| Decision date | Aug 5, 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: