InterStim® Therapy System, Verify® Evaluation System
FDA premarket approval P970004/S341 · decided 2021-08-24
Approval details
- PMA number
- P970004
- Supplement
- S341
- 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
- 2021-08-18
- Decision date
- 2021-08-24
- Days to decision
- 6 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Change to sterilization process, addition of the Cardiac Rhythm Management (CRM) sterilization area at the Villalba site for the sterilization of the leads (models 978A1 and 978B1) and extensions (models 3560022 and 3560030).
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |