This page includes the latest FDA filings for Kestra Medical Technologies Inc 3933 Lake Washington Boulevard N E Suite 200kirkland Wa 98033 Pma Numberp200037 Supplement Numbers004 Date Received06 02 2022 Decision Date10 25 2022 Product Code Mvk Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design Components Specifications Material 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 |
|---|---|---|
| Kestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS004 Date Received06/02/2022 Decision Date10/25/2022 Product Code MVK Advisory Committee Cardiovascular Supplement Typenormal 180 Day Track Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No | Assure Wearable Cardioverter Defibrillator (WCD) system | 2022-10-25 |