OVJ · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.3600
Classification
FDA Product Code
OVJ
Device class
Class II — Moderate Risk (510(k) clearance required)
Regulation
21 CFR 870.3600
Review panel
CV
Medical specialty
Cardiovascular
Submission type
1
GMP exempt
N
Life sustaining
Y
Implant
N
Third-party review
N
Definition
A dual chamber external pacemaker is intended to provide temporary dual chamber cardiac pacing as a substitute for the heart's intrinsic pacing system until a permanent pacemaker can be implanted, or to control irregular heartbeats following cardiac surgery or a myocardial infarction.