Axonics Sacral Neuromodulation System

FDA Premarket Approval P180046 S059

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

DeviceAxonics Sacral Neuromodulation System
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantAxonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS059 Date Received08/11/2022 Decision Date09/08/2022 Product Code EZW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-11
Decision Date2022-09-08
PMAP180046
SupplementS059
Product CodeEZW 
Advisory CommitteeGastroenterology/Urology
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressAxonics Modulation Technologies, Inc.
26 Technology Drive
irvine, CA 92618 PMA NumberP180046 Supplement NumberS059 Date Received08/11/2022 Decision Date09/08/2022 Product Code EZW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
approval To Add Deringer-Ney, Inc As An Alternate Supplier Of The Axonics Neurostimulator (Model 4101) Antenna Assembly

Supplemental Filings

Supplement NumberDateSupplement Type
P180046Original Filing
S060 2022-08-15 30-day Notice
S059 2022-08-11 30-day Notice
S058
S057 2022-06-30 30-day Notice
S056
S055 2022-04-15 30-day Notice
S054
S053
S052 2022-03-24 30-day Notice
S051 2022-02-07 30-day Notice
S050 2022-01-14 30-day Notice
S049 2022-01-05 30-day Notice
S048
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
10810005340486 P180046 000
10810005340431 P180046 015
10810005340424 P180046 015
10810005340455 P180046 038

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