| Device Type ID | 1033 |
| Device Name | System, Hemodynamic, Implantable |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Cardiac Diagnostics Devices Branch (CDDB) |
| Submission Type | PMA |
| FDA Device Classification | Class 3 Medical Device |
| Product Code | MOM |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | Yes |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 1033 |
| Device | System, Hemodynamic, Implantable |
| Product Code | MOM |
| FDA Device Classification | Class 3 Medical Device |
| Device Problems | |
|---|---|
Device Displays Incorrect Message | 857 |
Device Sensing Problem | 456 |
Adverse Event Without Identified Device Or Use Problem | 230 |
Sparking | 15 |
Communication Or Transmission Problem | 10 |
Smoking | 6 |
Material Frayed | 5 |
Improper Or Incorrect Procedure Or Method | 5 |
Failure To Advance | 3 |
Device Operates Differently Than Expected | 3 |
Failure To Sense | 3 |
Use Of Device Problem | 2 |
Difficult To Insert | 2 |
Difficult To Advance | 2 |
Detachment Of Device Or Device Component | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 1 |
Sensor | 1 |
Malposition Of Device | 1 |
Electrical Shorting | 1 |
Device Damaged By Another Device | 1 |
High Readings | 1 |
Connection Problem | 1 |
Guidewire | 1 |
| Total Device Problems | 1609 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Abbott Laboratories, Inc. | II | Jul-20-2018 |