Axonics Sacral Neuromodulation System

FDA Premarket Approval P190006 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 NameImplanted Electrical Device Intended For Treatment Of Fecal Incontinence
ApplicantAxonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS060 Date Received08/15/2022 Decision Date09/07/2022 Product Code QON  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
PMAP190006
SupplementS060
Product CodeQON 
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 NumberP190006 Supplement NumberS060 Date Received08/15/2022 Decision Date09/07/2022 Product Code QON  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
P190006Original 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 2019-12-30 30-day Notice
S002 2019-10-18 Real-time Process
S001

NIH GUDID Devices

Device IDPMASupp
10810005340387 P190006 000
10810005340158 P190006 000
10810005340141 P190006 000
10810005340134 P190006 000
10810005340127 P190006 000
10810005340103 P190006 000
10810005340080 P190006 000
10810005340066 P190006 000
10810005340059 P190006 000
10810005340035 P190006 000
10810005340028 P190006 000
10810005340189 P190006 000
10810005340196 P190006 000
10810005340219 P190006 000
10810005340370 P190006 000
10810005340325 P190006 000
10810005340301 P190006 000
10810005340288 P190006 000
10810005340271 P190006 000
10810005340264 P190006 000
10810005340257 P190006 000
10810005340240 P190006 000
10810005340233 P190006 000
10810005340226 P190006 000
10810005340011 P190006 000

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