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PMA P190006S009

Device
Axonics Sacral Neuromodulation System
Applicant
Boston Scientific Corporation
PMA number
P190006
Supplement
S009
Product code
QON
Decision date
2020-04-07
Generic name
Implanted electrical device intended for treatment of fecal 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
P190006
Supplement
S009
Product code
QON
Generic name
Implanted electrical device intended for treatment of fecal 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.