Axonics Sacral Neuromodulation System

FDA Premarket Approval P180046 S060

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 NumberS060 Date Received08/15/2022 Decision Date09/07/2022 Product Code EZW  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-15
Decision Date2022-09-07
PMAP180046
SupplementS060
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 NumberS060 Date Received08/15/2022 Decision Date09/07/2022 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 An Alternate Supplier For The Axonics Stimulation Cable Printed Circuit Board Assembly (PCBA)

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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