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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® PAD 350P (SAM 350P), samaritan® PAD 360P (SAM 360P), samaritan® PAD 450P (SAM 450P), Pad-Paks (Adult, Pediatr
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantHeartsine Technologies, Ltd.
207 Airport Rd. W.
Belfast BT3 9ED
PMA NumberP160008
Supplement NumberS026
Date Received07/29/2024
Decision Date10/09/2024
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 an additional labeling document referred to as the Visual Quick Start Guide (“VQSG”).
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