Definition: Detect Acute Coronary Syndrome Events And Prompt The Patient To Seek Medical Attention.
| Device Type ID | 1088 |
| Device Name | Acute Coronary Syndrome Event Detector |
| Physical State | Hermetically Sealed Electronics With A Flexible Lead For Intracardiac Placement |
| Technical Method | Monitoring The Intracardiac Electrogram For ST-segment Deviation Indicative Of Coronary Artery Occlusion. |
| Target Area | Heart |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | QBI |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1088 |
| Device | Acute Coronary Syndrome Event Detector |
| Product Code | QBI |
| FDA Device Classification | Class 3 Medical Device |