| Device |
pulse generator, external pacemaker, dual-chamber |
| Regulation Description |
External pacemaker pulse generator. |
| Definition |
A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction. |
| Physical State |
A system generally includes the pulse generator, extension cables, and adaptors. The pulse generator has a power supply and electronic components capable of data input, data output, and data processing. |
| Technical Method |
The device is used with either an endocardial (transluminal) or epicardial cardiac pacing leads system to deliver a period electrical pulse which stimulates the heart. |
| Target Area |
This device is used in the right atrium and right ventricle only. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | OVJ |
|---|
| Submission Type |
PMA
|
|---|
| Regulation Number |
870.3600
|
|---|
| Device Class |
3
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
| Recognized Consensus Standard
|
| Third Party Review |
Not Third Party Eligible |
