HeartSine samaritan® Public Access Automated External Defibrillators and Accessories

FDA Premarket Approval P160008 S019

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceHeartSine samaritan® Public Access Automated External Defibrillators and Accessories
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantHeartSine Technologies, Ltd.207 Airport Road Westbelfast, Northern Ireland BT3 9 PMA NumberP160008 Supplement NumberS019 Date Received03/28/2022 Decision Date05/31/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-03-28
Decision Date2022-05-31
PMAP160008
SupplementS019
Product CodeMKJ 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressHeartSine Technologies, Ltd.
207 Airport Road West
belfast, Northern Ireland BT3 9 PMA NumberP160008 Supplement NumberS019 Date Received03/28/2022 Decision Date05/31/2022 Product Code MKJ  Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
the Manufacturing Of The SAM 350P, SAM 360P And SAM 450P Defibrillators And Accessory Pad-Paks Using Certain Lead-free Components

Supplemental Filings

Supplement NumberDateSupplement Type
P160008Original Filing
S019 2022-03-28 Real-time Process
S018
S017
S016 2021-05-20 30-day Notice
S015 2020-10-28 30-day Notice
S014 2020-09-24 30-day Notice
S013
S012 2020-06-22 30-day Notice
S011
S010 2020-02-13 30-day Notice
S009
S008 2019-12-13 30-day Notice
S007 2019-10-31 30-day Notice
S006 2019-06-03 30-day Notice
S005 2019-02-01 30-day Notice
S004 2018-11-23 Real-time Process
S003 2018-11-21 30-day Notice
S002 2018-10-02 30-day Notice
S001 2018-09-11 30-day Notice

NIH GUDID Devices

Device IDPMASupp
05060167120695 P160008 004
05060167129773 P160008 004
05060167129735 P160008 004
05060167129711 P160008 004
05060167128066 P160008 004
05060167120916 P160008 004
05060167120893 P160008 004
05060167120886 P160008 004
05060167120701 P160008 004
05060167120671 P160008 004
05060167120688 P160008 004
05060167120718 P160008 004
05060167128080 P160008 004
05060167128042 P160008 004
05060167120909 P160008 004
05060167120862 P160008 004
05060167120855 P160008 004
05060167120725 P160008 004
M727PADPAK01 P160008 008
M727PADPAK02 P160008 008
05060167124488 P160008 008

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