FDA.reportPublic FDA data

PMA P180046S009

Device
Axonics Sacral Neuromodulation System
Applicant
Boston Scientific Corporation
PMA number
P180046
Supplement
S009
Product code
EZW
Decision date
2020-04-07
Generic name
Stimulator, electrical, implantable, for incontinence
Approval order statement
Update to the Implantable pulse generator (IPG) Model 1101 for the following:1) Ceramic case process change from machining to injection molding; and2) Addition of alternate suppliers and manufacturability improvements for braze ring and titanium flange components.

Current openFDA PMA Record#

Device
Axonics Sacral Neuromodulation System
Applicant
Boston Scientific Corporation
PMA number
P180046
Supplement
S009
Product code
EZW
Generic name
Stimulator, electrical, implantable, for incontinence
Decision date
2020-04-07
Decision code
OK30
Date received
2020-03-11
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Update to the Implantable pulse generator (IPG) Model 1101 for the following:1) Ceramic case process change from machining to injection molding; and2) Addition of alternate suppliers and manufacturability improvements for braze ring and titanium flange components.