PMA P240011S005

Device
Altaviva
Applicant
Medtronic Neuromodulation
PMA number
P240011
Supplement
S005
Product code
QPT
Decision date
2026-01-14
Classification
Gastroenterology, Urology
Generic name
Stimulator, tibial, electrical, implantable, for urinary incontinence
Approval order statement
approval for Perficio battery manufacturing process improvements

Current openFDA PMA Record#

Device
Altaviva
Applicant
Medtronic Neuromodulation
PMA number
P240011
Supplement
S005
Product code
QPT
Generic name
Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date
2026-01-14
Decision code
OK30
Date received
2025-12-17
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
approval for Perficio battery manufacturing process improvements