PMA P180046S061

Device: Axonics Sacral Neuromodulation System (Urinary)
Applicant: Boston Scientific Corporation
PMA number: P180046
Supplement: S061
Product code: EZW
Decision date: 2022-11-01
Generic name: Stimulator, electrical, implantable, for incontinence
Approval order statement: Approval for a manufacturing site located at Cirtec Medical Corporation, 99 Print Shop Road Enfield, CT 06082 as an alternate contract ethylene oxide sterilization facility for the Axonics Neurostimulator, Model 4101.

Current openFDA PMA Record#

Device: Axonics Sacral Neuromodulation System (Urinary)
Applicant: Boston Scientific Corporation
PMA number: P180046
Supplement: S061
Product code: EZW
Generic name: Stimulator, electrical, implantable, for incontinence
Decision date: 2022-11-01
Decision code: APPR
Date received: 2022-09-19
Supplement type: Normal 180 Day Track
Supplement reason: Location Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement: Approval for a manufacturing site located at Cirtec Medical Corporation, 99 Print Shop Road Enfield, CT 06082 as an alternate contract ethylene oxide sterilization facility for the Axonics Neurostimulator, Model 4101.