Axonics Sacral Neuromodulation System

FDA Premarket Approval P180046 S017

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

Axonics charging device uses a printed circuit board assembly (pcba) that is currently tested manually using test procedure, 120-0113 (vol# 27, file #009 of original submission). To support an increase in production, axonics developed a test fixture (# 200-0198-001, built with software 150-0113-001) that automates the tests that are in the original manual test procedure. A complete traceability of test steps in the original manual test procedure to the proposed automated test fixture requirements is provided

DeviceAxonics Sacral Neuromodulation System
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantAxonics Modulation Technologies, Inc.
Date Received2020-06-12
Decision Date2020-07-10
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
P180046Original 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
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
S005 2020-01-31 30-day Notice
S003 2020-01-17 30-day Notice

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