Definition: The System Is Indicated For Use In Postoperative Cardiac Surgery Patients Who Require Temporary Atrial Or Ventricular Pacing/sensing And/or Atrial Cardioversion. Epicardial Defibrillation Electrodes Can Be Implanted Up To 7 Days.
| Device Type ID | 899 |
| Device Name | Electrode, Pacing And Cardioversion, Temporary, Epicardial |
| Regulation Description | Cardiovascular Permanent Or Temporary Pacemaker Electrode. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Implantable Electrophysical Devices Branch (IEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.3680 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NHW |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 899 |
| Device | Electrode, Pacing And Cardioversion, Temporary, Epicardial |
| Product Code | NHW |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Cardiovascular Permanent Or Temporary Pacemaker Electrode. |
| CFR Regulation Number | 870.3680 [🔎] |