HeartSine’s samaritan Public Access Automated External Defibrillators and Accessories

Automated External Defibrillators (non-wearable)

FDA Premarket Approval P160008 S007

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

Change of supplier for cable assemblies.

DeviceHeartSine’s samaritan Public Access Automated External Defibrillators and Accessories
Classification NameAutomated External Defibrillators (non-wearable)
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantHeartSine Technologies, Ltd.
Date Received2019-10-31
Decision Date2019-11-19
PMAP160008
SupplementS007
Product CodeMKJ
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address HeartSine Technologies, Ltd. 203 Airport Road West belfast, Northern Ireland BT3 9

Supplemental Filings

Supplement NumberDateSupplement Type
P160008Original Filing
S021 2022-11-01 30-day Notice
S020 2022-08-29 Real-time Process
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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