InterStim® Therapy System, Verify® Evaluation System
FDA premarket approval P970004/S392 · decided 2023-12-12
Approval details
- PMA number
- P970004
- Supplement
- S392
- 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
- 2023-11-09
- Decision date
- 2023-12-12
- Days to decision
- 33 days
- Decision code
- OK30
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- implementation of updates to the H3 battery cathode mix manufacturing chloride specification and associated testing method for the InterStim Therapy System,Verify Evaluation System
Class III intelligence, same tools
PMAs share the API, exports and alerts with 510(k) data - watch an applicant and hear about every approval.
510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |