Axonics Modulation Technologies Inc 26 Technology Driveirvine Ca 92618 Pma Numberp190006 Supplement Numbers064 Date Received01 10 2023 Decision Date02 01 2023 Product Code Qon Advisory Committee Gastroenterology Urology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No

FDA Filings

This page includes the latest FDA filings for Axonics Modulation Technologies Inc 26 Technology Driveirvine Ca 92618 Pma Numberp190006 Supplement Numbers064 Date Received01 10 2023 Decision Date02 01 2023 Product Code Qon Advisory Committee Gastroenterology Urology Supplement Type30 Day Notice Supplement Reason Process Change Manufacturer Sterilizer Packager Supplier Expedited Review Granted No. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

FDA Filings

Device Company	Device	Date
PMA P190006S064 Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP190006 Supplement NumberS064 Date Received01/10/2023 Decision Date02/01/2023 Product Code QON  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Axonics Sacral Neuromodulation System	2023-02-01