Altaviva Implantable Neurostimulator
FDA premarket approval P240011/S001 · decided 2025-10-17
Approval details
- PMA number
- P240011
- Supplement
- S001
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Altaviva Implantable Neurostimulator
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Applicant
- Medtronic Neuromodulation
- Date received
- 2025-09-19
- Decision date
- 2025-10-17
- Days to decision
- 28 days
- Decision code
- OK30
- Product code
- QPT
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval to implement three manufacturing changes impacting the hybrid electronic module subassemblies including hybrid wafer visual inspection update for foreign material, hybrid final visual inspection criteria update, and hybrid manufacturing new vapor degreasing solvents
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |