Medtronic Altaviva System
FDA premarket approval P240011/S004 · decided 2025-12-19
Approval details
- PMA number
- P240011
- Supplement
- S004
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Medtronic Altaviva System
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2025-11-21
- Decision date
- 2025-12-19
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- QPT
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- The protocol modifications include the addition of quality-of-life, work productivity, mental health, and sexual health questionnaires. Additional revisions included changing "up to 30 institutions" to "approximately 30 institutions", requirements for appropriate investigator training, education, and experience, and updated language regarding the 6-month washout period for botulinum toxin therapy and sacral neuromodulation.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |