Premarket Approval (PMA)

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.

• Device: AngelMed Guardian System
• Generic Name: Acute coronary syndrome event detector
• Applicant: Avertix Medical Inc; 40 Christopher Way; Suite 201; Eatontown, NJ 07724
• PMA Number: P150009
• Supplement Number: S001
• Date Received: 05/09/2018
• Decision Date: 08/14/2018
• Product Code: QBI
• Advisory Committee: Cardiovascular
• Supplement Type: Normal 180 Day Track No User Fee
• Supplement Reason: Postapproval Study Protocol
• Expedited Review Granted?: No
• Combination Product: No

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.