This page includes the latest FDA filings for Axonics Modulation Technologies Inc 26 Technology Driveirvine Ca 92618 Pma Numberp190006 Supplement Numbers062 Date Received09 29 2022 Decision Date12 19 2022 Product Code Qon Advisory Committee Gastroenterology Urology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change Indications Instructions Shelf Life Tradename 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 NumberP190006 Supplement NumberS062 Date Received09/29/2022 Decision Date12/19/2022 Product Code QON Advisory Committee Gastroenterology/Urology Supplement Typenormal 180 Day Track Supplement Reason Labeling Change - Indications/instructions/shelf Life/tradename Expedited Review Granted? No | Axonics Sacral Neuromodulation System (bowel) | 2022-12-19 |