Pacing System Analyzer

FDA product code QAB · Class II (moderate risk) · 21 CFR 870.3605 · Cardiovascular

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.

0510(k) clearances
0PMA approvals
0recalls