samaritan Public Access Automated External Defibrillators and Accessories

FDA Premarket Approval P160008 S010

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

Addition of an alternate supplier for the main printed circuit board assembly

Devicesamaritan Public Access Automated External Defibrillators and Accessories
Generic NameAutomated External Defibrillators (non-wearable)
ApplicantHeartSine Technologies, Ltd.
Date Received2020-02-13
Decision Date2020-03-12
PMAP160008
SupplementS010
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
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

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