Medtronic Altaviva System
FDA premarket approval P240011 · decided 2025-09-18
Approval details
- PMA number
- P240011
- Trade name
- Medtronic Altaviva System
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2024-04-04
- Decision date
- 2025-09-18
- Days to decision
- 532 days
- Decision code
- APPR
- Product code
- QPT
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- Approval for the Medtronic Altaviva System is indicated for treatment of urge urinary incontinence (UUI) in patients who failed or could not tolerate more conservative treatments.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |