InterStim® Therapy System, Verify® Evaluation System
FDA premarket approval P970004/S342 · decided 2022-02-18
Approval details
- PMA number
- P970004
- Supplement
- S342
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- InterStim® Therapy System, Verify® Evaluation System
- Generic name
- Stimulator, electrical, implantable, for incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2021-09-07
- Decision date
- 2022-02-18
- Days to decision
- 164 days
- Decision code
- APPR
- Product code
- EZW
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the use of electronic labeling as a primary medium for distributing Neuromodulation and Pelvic Health product labeling to patients.
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 |