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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 (SAM 350P, SAM 360P and SAM 450P)
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantHeartsine Technologies, Ltd.
207 Airport Rd. W.
Belfast BT3 9ED
PMA NumberP160008
Supplement NumberS030
Date Received09/05/2025
Decision Date09/29/2025
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval for a shelf-life extension of the Pad-Pak (combined battery and electrode pack) from 4.25 years to 5.25 years
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