This page includes the latest FDA filings for Axonics Modulation Technologies Inc 26 Technology Driveirvine Ca 92618 Pma Numberp180046 Supplement Numbers061 Date Received09 19 2022 Decision Date11 01 2022 Product Code Ezw Advisory Committee Gastroenterology Urology Supplement Typenormal 180 Day Track Supplement Reason Location 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.
Device Company | Device | Date |
|---|---|---|
| Axonics Modulation Technologies, Inc.26 Technology Driveirvine, CA 92618 PMA NumberP180046 Supplement NumberS061 Date Received09/19/2022 Decision Date11/01/2022 Product Code EZW Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Location Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No | Axonics Sacral Neuromodulation System (Urinary) | 2022-11-01 |