Axonics Modulation Technologies Inc 26 Technology Driveirvine Ca 92618 Pma Numberp170023 Supplement Numbers012 Date Received09 27 2022 Decision Date10 26 2022 Product Code Lnm 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 Numberp170023 Supplement Numbers012 Date Received09 27 2022 Decision Date10 26 2022 Product Code Lnm 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 P170023S012 Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP170023 Supplement NumberS012 Date Received09/27/2022 Decision Date10/26/2022 Product Code LNM  Advisory Committee Gastroenterology/Urology Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	Bulkamid Urethral Bulking System	2022-10-26