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
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

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