Heartsine Technologies L T D 207 Airport Road Westbelfast Northern Ireland Bt3 9 Pma Numberp160008 Supplement Numbers020 Date Received08 29 2022 Decision Date11 23 2022 Product Code Mkj Advisory Committee Cardiovascular Supplement Typereal Time Process Supplement Reason Change Design Components Specifications Material 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 Numbers020 Date Received08 29 2022 Decision Date11 23 2022 Product Code Mkj Advisory Committee Cardiovascular Supplement Typereal Time Process 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.

FDA Filings

Device Company	Device	Date
PMA P160008S020 HeartSine Technologies, Ltd.207 Airport Road Westbelfast, Northern Ireland BT3 9 PMA NumberP160008 Supplement NumberS020 Date Received08/29/2022 Decision Date11/23/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No	HeartSine samaritan® Public Access Automated External Defibrillators and Accessories	2022-11-23