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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.
 
DeviceGuardian System
Generic NameAcute coronary syndrome event detector
ApplicantAvertix Medical Inc
40 Christopher Way
Suite 201
Eatontown, NJ 07724
PMA NumberP150009
Supplement NumberS009
Date Received04/18/2023
Decision Date08/10/2023
Product Code QBI 
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 a trade name change to The Guardian System.
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