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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 samaritan® Public Access Automated External Defibrillators and Accessories
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantHeartsine Technologies, Ltd.
207 Airport Rd. W.
Belfast BT3 9ED
PMA NumberP160008
Supplement NumberS019
Date Received03/28/2022
Decision Date05/31/2022
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the manufacturing of the SAM 350P, SAM 360P and SAM 450P defibrillators and accessory Pad-Paks using certain lead-free components.
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