MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
FDA premarket approval P970004/S197 · decided 2016-10-04
Approval details
- PMA number
- P970004
- Supplement
- S197
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- MEDTRONIC INTERSTIM SACRAL NERVE STIMULATION THERAPY SYSTEM
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2015-04-20
- Decision date
- 2016-10-04
- Days to decision
- 533 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a labeling update to incorporate data from the now completed, randomized 6 month cohort (Phase I) and 12 month data from the ongoing, nonrandomized study cohort (Phase II).
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |