PMA P190006S030

Device: Axonics Sacral Neuromodulation (SNM) System Urinary Control
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S030
Product code: QON
Decision date: 2021-03-01
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Approval order statement: Change the manufacturing process method for the hole in the PNE Lead stylet handle from being drilled/machined through the molded handle to molding the hole directly into the handle.

Current openFDA PMA Record#

Device: Axonics Sacral Neuromodulation (SNM) System Urinary Control
Applicant: Boston Scientific Corporation
PMA number: P190006
Supplement: S030
Product code: QON
Generic name: Implanted electrical device intended for treatment of fecal incontinence
Decision date: 2021-03-01
Decision code: OK30
Date received: 2021-02-01
Supplement type: 30-Day Notice
Supplement reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Change the manufacturing process method for the hole in the PNE Lead stylet handle from being drilled/machined through the molded handle to molding the hole directly into the handle.