Axonics Sacral Neuromodulation (SNM) System

FDA Premarket Approval P180046 S003

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 an additional sterilization chamber.

DeviceAxonics Sacral Neuromodulation (SNM) System
Generic NameStimulator, Electrical, Implantable, For Incontinence
ApplicantAxonics Modulation Technologies, Inc.
Date Received2020-01-17
Decision Date2020-01-30
PMAP180046
SupplementS003
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
S003 2020-01-17 30-day Notice
S002
S001

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