Kestra Medical Technologies Inc 3933 Lake Washington Boulevard N E Suite 200kirkland Wa 98033 Pma Numberp200037 Supplement Numbers005 Date Received09 28 2022 Decision Date10 27 2022 Product Code Mvk Advisory Committee Cardiovascular 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 Kestra Medical Technologies Inc 3933 Lake Washington Boulevard N E Suite 200kirkland Wa 98033 Pma Numberp200037 Supplement Numbers005 Date Received09 28 2022 Decision Date10 27 2022 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.

FDA Filings

Device Company	Device	Date
PMA P200037S005 Kestra Medical Technologies, Inc.3933 Lake Washington Boulevard, N.e.suite 200kirkland, WA 98033 PMA NumberP200037 Supplement NumberS005 Date Received09/28/2022 Decision Date10/27/2022 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 (WCD) System	2022-10-27