Definition: Call For PMAs 12/26/96 (61 FR 50706 9/27/96)) Patients Who Are Icd Indicated And Who Have Atrial Tachyarrhythmias, Or Who Are At Risk Of Developing Atrial Tachyarrhythmias.
| Device Type ID | 885 |
| Device Name | Atrial Defibrillator |
| Regulation Description | DC-defibrillator (including Paddles). |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | PMA |
| CFR Regulation Number | 870.5300 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MPC |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | Yes |
| Life Support Device | Yes |
| Third Party Review | Not Third Party Eligible |
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| Device Type ID | 885 |
| Device | Atrial Defibrillator |
| Product Code | MPC |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | DC-defibrillator (including Paddles). |
| CFR Regulation Number | 870.5300 [🔎] |