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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 Road West
Belfast, Northern Ireland BT3 9
PMA NumberP160008
Supplement NumberS022
Date Received10/18/2023
Decision Date11/13/2023
Product Code MKJ 
Advisory Committee Cardiovascular
Supplement Type30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
to implement minor manufacturing process (assembly) changes for the Adult Pad-Pak
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