Altaviva Implantable Neurostimulator
FDA premarket approval P240011/S002 · decided 2025-10-21
Approval details
- PMA number
- P240011
- Supplement
- S002
- 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
- 2025-09-22
- Decision date
- 2025-10-21
- Days to decision
- 29 days
- Decision code
- OK30
- Product code
- QPT
- Advisory committee
- Gastroenterology, Urology
- Expedited review
- No
- Location
- Minneapolis, MN
- Statement
- approval of a manufacturing site change for Heraeus Medical Components and the addition of Electrical Discharge Machining (EDM) to the manufacturing process of feedthrough pins, process updates to feedthrough and hermetic testing operations including leak testing, implementation of a new sputter monitor visual inspection for the presence of unintended gold material between the feedthrough component and the tri-metal sputtered layer.
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510(k) clearances by this applicant
| Record | Firm | Date |
|---|---|---|
| SureTune4 Software (DEN210003) | Medtronic Neuromodulation | 2021-08-23 |