PMA P240011S011

Device: Altaviva™
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S011
Product code: QPT
Decision date: 2026-03-26
Classification: Gastroenterology, Urology
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Approval order statement: approval for several administrative changes to the protocol and for Medtronic Neuromodulation to provide the commercial Altaviva™ system at no cost to study sites

Current openFDA PMA Record#

Device: Altaviva™
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S011
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2026-03-26
Decision code: APPR
Date received: 2026-02-24
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: approval for several administrative changes to the protocol and for Medtronic Neuromodulation to provide the commercial Altaviva™ system at no cost to study sites