PMA P240011S010
- Device
- Altaviva™
- Applicant
- Medtronic Neuromodulation
- PMA number
- P240011
- Supplement
- S010
- Product code
- QPT
- Decision date
- 2026-07-13
- Classification
- Gastroenterology, Urology
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Approval order statement
- Approval of updated labeling for the Altaviva™ system to incorporate the 24-month results from the TITAN 2 clinical study.
Current openFDA PMA Record#
- Device
- Altaviva™
- Applicant
- Medtronic Neuromodulation
- PMA number
- P240011
- Supplement
- S010
- Product code
- QPT
- Generic name
- Stimulator, tibial, electrical, implantable, for urinary incontinence
- Decision date
- 2026-07-13
- Decision code
- APPR
- Date received
- 2026-02-19
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Approval order statement
- Approval of updated labeling for the Altaviva™ system to incorporate the 24-month results from the TITAN 2 clinical study.