InterStim Therapy System
FDA premarket approval P970004/S340 · decided 2022-02-22
Approval details
- PMA number
- P970004
- Supplement
- S340
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- InterStim Therapy System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-08-13
- Decision date
- 2022-02-22
- Days to decision
- 193 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the InterStim X INS (Model 97800) and its associated software applications (Model A51300, Model A52300).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |