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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 Public Access Automated External Defibrillators and Accessories
Generic NameAutomated external defibrillators (non-wearable)
Regulation Number870.5310
ApplicantHeartSine Technologies, Ltd.
207 Airport Road West
Belfast, Northern Ireland BT3 9
PMA NumberP160008
Supplement NumberS016
Date Received05/20/2021
Decision Date06/08/2021
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  
Implement changes to the manufacturing equipment used to seal pouches and stud the electrodes.
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