| Device Type ID | 846 |
| Device Name | Materials, Repair Or Replacement, Pacemaker |
| Regulation Description | Pacemaker Repair Or Replacement Material. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Interventional Cardiology Devices Branch (ICDB) |
| Submission Type | PMA |
| CFR Regulation Number | 870.3710 [🔎] |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | KFJ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 846 |
| Device | Materials, Repair Or Replacement, Pacemaker |
| Product Code | KFJ |
| FDA Device Classification | Class 3 Medical Device |
| Regulation Description | Pacemaker Repair Or Replacement Material. |
| CFR Regulation Number | 870.3710 [🔎] |