PMA P240011S002

Device: Altaviva™ Implantable Neurostimulator
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S002
Product code: QPT
Decision date: 2025-10-21
Classification: Gastroenterology, Urology
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Approval order 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.

Current openFDA PMA Record#

Device: Altaviva™ Implantable Neurostimulator
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S002
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2025-10-21
Decision code: OK30
Date received: 2025-09-22
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order 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.