Axonics Sacral Neuromodulation System

FDA Premarket Approval P190006 S011

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

Approval for the addition of “3t mri rf body coil conditional” to the labeling.

DeviceAxonics Sacral Neuromodulation System
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantAxonics Modulation Technologies, Inc.
Date Received2020-04-02
Decision Date2020-07-01
PMAP190006
SupplementS011
Product CodeEZW 
Advisory CommitteeGastroenterology/Urology
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address Axonics Modulation Technologies, Inc. 26 Technology Drive irvine, CA 92618

Supplemental Filings

Supplement NumberDateSupplement Type
P190006Original Filing
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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