PMA P190006S002

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S002
Product code: QON
Decision date: 2019-12-12
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Approval for changes to the Charging Device (CD), model 1401, which included a new rechargeable Li-ion battery, a new speaker, and corresponding software changes.

Current openFDA PMA Record#

Device: Axonics Sacral Neuromodulation System
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S002
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2019-12-12
Decision code: APPR
Date received: 2019-10-18
Supplement type: Real-Time Process
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for changes to the Charging Device (CD), model 1401, which included a new rechargeable Li-ion battery, a new speaker, and corresponding software changes.