QAB

Pacing System Analyzer

Product code: QAB
Device name: Pacing System Analyzer
Device class: Class 2
21 CFR: 21 CFR 870.3605
Medical specialty: Cardiovascular
Marketing pathway: 510(K)
Flag: Life-sustaining / life-supporting

FDA classification definition

The device is intended to supply an accurately calibrated, variable pacing pulse for measuring the patients 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.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

Official FDA classification page: QAB

Classification and pathway per current FDA publications. Data from openFDA (CC0).