QAB · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3605
Classification
FDA Product Code
QAB
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.3605
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
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.