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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 350P (SAM350P) Automated External Defibrillator
Generic Nameover-the-counter automated external defibrillator
Regulation Number870.5310
ApplicantHeartSine Technologies, Ltd.
207 airport road west
belfast, northern ireland BT3 9
PMA NumberP160008
Supplement NumberS017
Date Received03/17/2022
Decision Date06/23/2022
Product Code NSA 
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
Approval for change to the Indications for Use (IFU) from prescription to Over-the-Counter (OTC) use with associated labeling changes.
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