Interstim Therapy System, Verify Evaluation System
FDA premarket approval P970004/S300 · decided 2019-10-10
Approval details
- PMA number
- P970004
- Supplement
- S300
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- Interstim Therapy System, Verify Evaluation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2019-09-12
- Decision date
- 2019-10-10
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval to modify the Verify External Neurostimulator User Manual by 1) adding a warning regarding making connections outside the sterile field; and 2) adding a caution regarding battery depletion and replacement.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |