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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.
 
DeviceAngelMed Guardian System
Generic NameAcute coronary syndrome event detector
ApplicantCJ Healthtech Holdings, LLC
125 Shore Ct.
Unit 208a
North Palm Beach, FL 33408
PMA NumberP150009
Supplement NumberS001
Date Received05/09/2018
Decision Date08/14/2018
Product Code QBI 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for the AngelMed Guardian System. This device is an implantable cardiac monitor with patient alerting capability and an additional external alarm device. The device is indicated for use in patients who have had prior acute coronary syndrome (ACS) events and who remain at high risk for recurrent ACS events.The Guardian System is indicated as an adjunct to patient recognized symptoms. The Guardian System detects potential ongoing ACS events, characterized by sustained ST segment changes, and alerts the patient to seek medical attention for those potential ACS events.A Guardian System alert is a more accurate predictor of ACS events when compared to patient recognized symptoms alone and demonstrates a reduced rate over time of patient presentations without ACS events (false positives) when compared to patient recognized symptoms alone.In the absence of symptoms, the Guardian System may identify asymptomatic ACS events and prompt the patient to seek medical attention.
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