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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
ApplicantHeartSine Technologies, Ltd.
207 Airport Road West
Belfast, Northern Ireland BT3 9
PMA NumberP160008
Supplement NumberS009
Date Received02/03/2020
Decision Date04/30/2020
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for labeling changes for the SAM350P, SAM360P and SAM 450P public access defibrillators and Pad-Pak accessories.
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