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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.
 
Devicesamaritan Public Access Automated External Defibrillators 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 NumberS001
Date Received09/11/2018
Decision Date10/09/2018
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 
Implementation of an alternative manufacturing process (selective soldering) for soldering through-hole components on the printed circuit board assemblies used in the SAM 350P and SAM 360P public access defibrillators.
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