PMA P240011

Device: Altaviva™
Applicant: Medtronic Neuromodulation
Product code: QPT
Decision date: 2026-06-16
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Approval order statement: Replacement of the existing laser cutting workstation used in the manufacturing process of Lithium-Ion Intellis and Perficio batteries for Medtronic Neuromodulation devices.

Current openFDA PMA Record#

Device: Altaviva™
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S014
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2026-06-16
Decision code: OK30
Date received: 2026-05-28
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Replacement of the existing laser cutting workstation used in the manufacturing process of Lithium-Ion Intellis and Perficio batteries for Medtronic Neuromodulation devices.