PMA P240011S012

Device: Altaviva™
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S012
Product code: QPT
Decision date: 2026-04-03
Classification: Gastroenterology, Urology
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Approval order statement: approval for an update to the equipment used to perform final functional testing on Medtronic Neuromodulation and Pelvic Health implantable devices

Current openFDA PMA Record#

Device: Altaviva™
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S012
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2026-04-03
Decision code: OK30
Date received: 2026-03-09
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval for an update to the equipment used to perform final functional testing on Medtronic Neuromodulation and Pelvic Health implantable devices