Axonics Sacral Neuromodulation System

FDA Premarket Approval P180046 S045

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

Removal of the x-ray inspection step from receiving inspection for the tined lead

DeviceAxonics Sacral Neuromodulation System
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantAxonics Modulation Technologies, Inc.
Date Received2021-12-07
Decision Date2021-12-28
PMAP180046
SupplementS045
Product CodeEZW 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Axonics Modulation Technologies, Inc. 26 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P180046Original Filing
S047 2021-12-15 30-day Notice
S046
S045 2021-12-07 30-day Notice
S044
S043 2021-10-27 30-day Notice
S042 2021-10-18 30-day Notice
S041
S040
S039
S038
S037 2021-04-26 30-day Notice
S036
S035
S034 2021-02-25 30-day Notice
S033 2021-02-16 30-day Notice
S032 2021-02-08 30-day Notice
S031 2021-02-01 30-day Notice
S030 2021-02-01 30-day Notice
S029 2021-01-25 30-day Notice
S028
S027
S026 2020-11-05 Real-time Process
S025
S024
S023 2020-10-06 30-day Notice
S022 2020-10-02 30-day Notice
S021 2020-08-24 30-day Notice
S020
S019 2020-07-02 30-day Notice
S018 2020-06-16 30-day Notice
S017 2020-06-12 30-day Notice
S016 2020-06-05 30-day Notice
S015
S014
S013
S012
S011 2020-04-02 Normal 180 Day Track
S010 2020-03-16 30-day Notice
S009 2020-03-11 30-day Notice
S008 2020-03-06 30-day Notice
S007 2020-03-06 30-day Notice
S006
S005 2020-01-31 30-day Notice
S004
S003 2020-01-17 30-day Notice
S002
S001

NIH GUDID Devices

Device IDPMASupp
10810005340431 P180046 015
10810005340424 P180046 015

© 2022 FDA.report
This site is not affiliated with or endorsed by the FDA.