- Device
- Altaviva™ Tibial Neuromodulation System (Altaviva™ P7850N)
- Applicant
- Medtronic Neuromodulation
- PMA number
- P240011
- Supplement
- S007
- Product code
- QPT
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Decision date
- 2026-02-06
- Decision code
- OK30
- Date received
- 2026-01-27
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- approval to implement process changes in the manufacture of the 90nm Integrated Circuit (IC) wafer components on behalf of an external supplier