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 Numbers006 Date Received12 12 2022 Decision Date01 10 2023 Product Code Mvk Advisory Committee Cardiovascular 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.
Device Company | Device | Date |
|---|---|---|
| Kestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS006 Date Received12/12/2022 Decision Date01/10/2023 Product Code MVK Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No | ASSURE Wearable Cardioverter Defibrillator system (ASSURE system) | 2023-01-10 |