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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 Technologies LLC's samaritan 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 NumberS004
Date Received11/23/2018
Decision Date02/19/2019
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for minor changes including the addition of EMC suppression circuitry, PCBA and membrane standardization, related manufacturing changes, and labeling updates.
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