Heartsine Technologies L T D 207 Airport Road Westbelfast Northern Ireland Bt3 9 Pma Numberp160008 Supplement Numbers021 Date Received11 01 2022 Decision Date11 23 2022 Product Code Mkj 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 Heartsine Technologies L T D 207 Airport Road Westbelfast Northern Ireland Bt3 9 Pma Numberp160008 Supplement Numbers021 Date Received11 01 2022 Decision Date11 23 2022 Product Code Mkj 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 P160008S021 HeartSine Technologies, Ltd.207 Airport Road Westbelfast, Northern Ireland BT3 9 PMA NumberP160008 Supplement NumberS021 Date Received11/01/2022 Decision Date11/23/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No	HeartSine’s samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories	2022-11-23