| Device |
pacing system analyzer |
| Regulation Description |
Pacing system analyzer. |
| Definition |
The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patient’s pacing threshold and intracardiac R-wave potential. A pacing system analyzer (PSA) may be a single, dual, or triple chamber system and can simultaneously deliver pacing therapy while testing one or more implanted pacing leads. |
| 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 an implanted (transluminal) cardiac lead system to deliver a period electrical pulses. |
| Target Area |
Any area of the heart with an implanted cardiac lead. |
| Regulation Medical Specialty |
Cardiovascular |
| Review Panel |
Cardiovascular |
|---|
| Product Code | QAB |
|---|
| Premarket Review |
Office of Cardiovascular Devices
(OHT2)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices
(DHT2A)
|
| Submission Type |
510(k)
|
|---|
| Regulation Number |
870.3605
|
|---|
| Device Class |
2
|
| Total Product Life Cycle (TPLC) |
TPLC Product Code Report
|
| GMP Exempt? |
No
|
Summary Malfunction
Reporting |
Ineligible |
| Implanted Device? |
No
|
|---|
| Life-Sustain/Support Device? |
Yes
|
|---|
| Third Party Review |
Not Third Party Eligible |
|
|
