FDA.reportPublic FDA data

PMA P190006S010

Device
Axonics Sacral Neuromodulation System
Applicant
Boston Scientific Corporation
PMA number
P190006
Supplement
S010
Product code
QON
Decision date
2020-04-10
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Approval order statement
Inclusion of NAMSA Inc. and LGGC Inc. as additional testing laboratories to perform biological indicator (BI) sterility testing and bacterial endotoxin testing (BET) for the Axonics Sacral Neuromodulation System.

Current openFDA PMA Record#

Device
Axonics Sacral Neuromodulation System
Applicant
Boston Scientific Corporation
PMA number
P190006
Supplement
S010
Product code
QON
Generic name
Implanted electrical device intended for treatment of fecal incontinence
Decision date
2020-04-10
Decision code
OK30
Date received
2020-03-16
Supplement type
30-Day Notice
Supplement reason
Process Change - Manufacturer/Sterilizer/Packager/Supplier
Approval order statement
Inclusion of NAMSA Inc. and LGGC Inc. as additional testing laboratories to perform biological indicator (BI) sterility testing and bacterial endotoxin testing (BET) for the Axonics Sacral Neuromodulation System.