InterStim Therapy System, Verify Evaluation System
FDA premarket approval P970004/S428 · decided 2025-07-17
Approval details
- PMA number
- P970004
- Supplement
- S428
- 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
- 2025-06-20
- Decision date
- 2025-07-17
- Days to decision
- 27 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- reduced bacterial endotoxin testing frequency and sample size for the Connector Plug Accessory Kit (model B31060), the Bolero Interstim Revision Kit (model 3560031), the Tunneling Tools and Catheter Passers, the Torque Wrenches and Injex families manufactured at Juncos, Puerto Rico facility
Class III intelligence, same tools
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |