Master InterStim Therapy System, Verify Evaluation System
FDA premarket approval P970004/S367 · decided 2022-08-19
Approval details
- PMA number
- P970004
- Supplement
- S367
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Master InterStim Therapy System, Verify Evaluation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2022-05-23
- Decision date
- 2022-08-19
- Days to decision
- 88 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for a layout change to the L408 integrated circuit used in the model 97810 InterStim Micro Implantable Neurostimulator (INS) and model 97800 InterStim X INS
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |