Axonics Sacral Neuromodulation (SNM) System for Bowel Control

FDA Premarket Approval P180046 S033

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

Qualification of heraeus medical components as an alternate supplier of the axonics leads.

DeviceAxonics Sacral Neuromodulation (SNM) System for Bowel Control
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantAxonics Modulation Technologies, Inc.
Date Received2021-02-16
Decision Date2021-03-16
PMAP180046
SupplementS033
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
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

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