510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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OVJClass II

Pulse Generator, External Pacemaker, Dual Chamber

21 CFR 870.3600 / Cardiovascular
FDA source (opens on fda.gov)

OVJ is the FDA product code for Pulse Generator, External Pacemaker, Dual Chamber, a class II device type, regulated under 21 CFR 870.3600. FDA's definition for this code reads: "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". As of , FDA records hold no 510(k) clearances under this code and no recalls.

Classification record

Product code
OVJ
Device name
Pulse Generator, External Pacemaker, Dual Chamber
FDA 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.
Regulation
21 CFR 870.3600
Device class
Class II
Review panel
Cardiovascular
Submission type
510(k)
Implant
No
Life sustaining or supporting
Yes
GMP exempt
No
Third party review eligible
No
Ingested clearances
0
Ingested recalls
0

Companies listing this code with FDA

Companies whose registered establishments list this code