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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: 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.
 
DeviceHeartSine samaritan Public Access Automated External Defibrillators (SAM 350P, SAM 360P, and SAM 450P) and Accessories
Generic Nameautomated external defibrillators (non-wearable)
Regulation Number870.5310
Applicant
HeartSine Technologies, Ltd.
207 airport road west
belfast, northern ireland BT3 9
PMA NumberP160008
Supplement NumberS014
Date Received09/24/2020
Decision Date10/22/2020
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
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).
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