PMA P240011S001

Device: Altaviva™ Implantable Neurostimulator
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S001
Product code: QPT
Decision date: 2025-10-17
Classification: Gastroenterology, Urology
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Approval order statement: approval to implement three manufacturing changes impacting the hybrid electronic module subassemblies including hybrid wafer visual inspection update for foreign material, hybrid final visual inspection criteria update, and hybrid manufacturing new vapor degreasing solvents

Current openFDA PMA Record#

Device: Altaviva™ Implantable Neurostimulator
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S001
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2025-10-17
Decision code: OK30
Date received: 2025-09-19
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: approval to implement three manufacturing changes impacting the hybrid electronic module subassemblies including hybrid wafer visual inspection update for foreign material, hybrid final visual inspection criteria update, and hybrid manufacturing new vapor degreasing solvents