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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’s samaritan® Public Access Automated External Defibrillators (SAM 350P, SAM 360P and SAM 450P) and Accessories
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantHeartsine Technologies, Ltd.
207 Airport Rd. W.
Belfast BT3 9ED
PMA NumberP160008
Supplement NumberS029
Date Received08/18/2025
Decision Date09/02/2025
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeSpecial (Immediate Track)
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for supplemental labeling to communicate the correct insertion and connection of a Pad-Pak
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