| Device Type ID | 895 |
| Device Name | Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Regulation Description | Arrhythmia Detector And Alarm (including ST-segment Measurement And Alarm). |
| 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 | 510(k) |
| CFR Regulation Number | 870.1025 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MXD |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 895 |
| Device | Recorder, Event, Implantable Cardiac, (with Arrhythmia Detection) |
| Product Code | MXD |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Arrhythmia Detector And Alarm (including ST-segment Measurement And Alarm). |
| CFR Regulation Number | 870.1025 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BIOTRONIK GMBG & CO. | ||
SUBSTANTIALLY EQUIVALENT | 5 | |
BIOTRONIK, INC. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
| Device Problems | |
|---|---|
Adverse Event Without Identified Device Or Use Problem | 63 |
Device Dislodged Or Dislocated | 6 |
Device Displays Incorrect Message | 5 |
Battery Problem | 5 |
Failure To Interrogate | 3 |
Migration Or Expulsion Of Device | 2 |
Ambient Noise Problem | 2 |
Device Expiration Issue | 2 |
Insufficient Information | 2 |
Malposition Of Device | 1 |
Premature Elective Replacement Indicator | 1 |
Under-Sensing | 1 |
Device Damaged By Another Device | 1 |
Failure To Sense | 1 |
Bent | 1 |
Device Sensing Problem | 1 |
Failure To Transmit Record | 1 |
No Apparent Adverse Event | 1 |
Appropriate Term/Code Not Available | 1 |
| Total Device Problems | 100 |