Axonics Sacral Neuromodulation (SNM) System

FDA Premarket Approval P190006 S005

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

To add a second supplier for machining the ceramic casing

DeviceAxonics Sacral Neuromodulation (SNM) System
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantAxonics Modulation Technologies, Inc.
Date Received2020-01-31
Decision Date2020-02-28
PMAP190006
SupplementS005
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
P190006Original Filing
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
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10810005340028 P190006 000
10810005340189 P190006 000
10810005340196 P190006 000
10810005340219 P190006 000
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10810005340288 P190006 000
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10810005340257 P190006 000
10810005340240 P190006 000
10810005340233 P190006 000
10810005340226 P190006 000
10810005340011 P190006 000

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