Master InterStim Therapy System, Verify Evaluation System (SNS Urinary Programming Systems)
FDA premarket approval P970004/S247 · decided 2017-09-25
Approval details
- PMA number
- P970004
- Supplement
- S247
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- Master InterStim Therapy System, Verify Evaluation System (SNS Urinary Programming Systems)
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2017-06-27
- Decision date
- 2017-09-25
- Days to decision
- 90 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval of new Model A511 clinician programmer application and Model A521 patient programmer application; labeling change; and packaging change.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |