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 |
|
|