Acute Coronary Syndrome Event Detector
Basic Information
- Device Name
- Acute Coronary Syndrome Event Detector
- Trade Name
- Guardian System
- PMA Number
- P150009
- 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
- April 9, 2018
- Date Received
- February 23, 2015
- Expedited Review
- N
- Docket Number
- 18M-1447
Advisory Committee Statement
Approval of the AngelMed Guardian System. This 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 |