InterStim® Therapy System, Verify® Evaluation System
FDA premarket approval P970004/S419 · decided 2025-02-28
Approval details
- PMA number
- P970004
- Supplement
- S419
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- InterStim® Therapy System, Verify® Evaluation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2025-02-06
- Decision date
- 2025-02-28
- Days to decision
- 22 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- the approval of a manufacturing site change for Heraeus Medical Components and the addition of Electrical Discharge Machining (EDM) to the manufacturing process of the feedthrough pins that are welded into the batteries manufactured at Medtronic Energy and Component Center (Located in Brooklyn Center, MN)
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |