FDA.reportPublic FDA data

PMA P180046S010

Device
Axonics Sacral Neuromodulation System
Applicant
Boston Scientific Corporation
PMA number
P180046
Supplement
S010
Product code
EZW
Decision date
2020-04-10
Generic name
Stimulator, electrical, implantable, for 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
P180046
Supplement
S010
Product code
EZW
Generic name
Stimulator, electrical, implantable, for 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.