HeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories

FDA Premarket Approval P160008 S014

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

Modifications to the soldering method used for seven (7) specific plated through-hole (pth) components from selective soldering to manual soldering and adding manual cleaning of the test point pads of the printed circuit board assembly (pcba)

DeviceHeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantHeartSine Technologies, Ltd.
Date Received2020-09-24
Decision Date2020-10-22
PMAP160008
SupplementS014
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
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
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M727PADPAK02 P160008 008
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05060167124488 P160008 008

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