PMA P240011S004

Device: Medtronic Altaviva System
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S004
Product code: QPT
Decision date: 2025-12-19
Classification: Gastroenterology, Urology
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Approval order statement: The protocol modifications include the addition of quality-of-life, work productivity, mental health, and sexual health questionnaires. Additional revisions included changing "up to 30 institutions" to "approximately 30 institutions", requirements for appropriate investigator training, education, and experience, and updated language regarding the 6-month washout period for botulinum toxin therapy and sacral neuromodulation.

Current openFDA PMA Record#

Device: Medtronic Altaviva System
Applicant: Medtronic Neuromodulation
PMA number: P240011
Supplement: S004
Product code: QPT
Generic name: Stimulator, tibial, electrical, implantable, for urinary incontinence
Decision date: 2025-12-19
Decision code: APPR
Date received: 2025-11-21
Supplement type: Normal 180 Day Track No User Fee
Supplement reason: Postapproval Study Protocol
Approval order statement: The protocol modifications include the addition of quality-of-life, work productivity, mental health, and sexual health questionnaires. Additional revisions included changing "up to 30 institutions" to "approximately 30 institutions", requirements for appropriate investigator training, education, and experience, and updated language regarding the 6-month washout period for botulinum toxin therapy and sacral neuromodulation.