Acute Coronary Syndrome Event Detector
Basic Information
- Device Name
- Acute Coronary Syndrome Event Detector
- Trade Name
- AngelMed Guardian System
- PMA Number
- P150009
- Supplement Number
- S001
- Device Class
- FDA Class 3
- Product Code
- QBI
- Generic Name
- Acute coronary syndrome event detector
- Medical Specialty
- Unknown
- Advisory Committee
- Cardiovascular
- Decision
- Approved
- Decision Code
- APPR
- Decision Date
- August 14, 2018
- Date Received
- May 9, 2018
- Supplement Type
- Normal 180 Day Track No User Fee
- Supplement Reason
- Postapproval Study Protocol
- Expedited Review
- N
Advisory Committee 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.
Classifications
This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| QBI | Acute Coronary Syndrome Event Detector | FDA class 3 | Unknown |