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 [🔎] |