Pulse Generator, External Pacemaker, Dual Chamber
The Pulse Generator, External Pacemaker, Dual Chamber (product code OVJ) is an external cardiovascular device 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. It stimulates both the atrium and ventricle in a coordinated manner. As an FDA Class 2 device under regulation 870.3600, it requires 510(k) premarket clearance and falls within the Cardiovascular specialty. The device is flagged as life-sustaining and is not an implant.
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Basic Information
- Product Code
- OVJ
- Device Class
- FDA class 2
- Regulation Number
- 870.3600
- Medical Specialty
- Cardiovascular
- Review Panel
- CV
- Submission Type
- 1
Device Characteristics
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.
FEI Numbers
This FDA classification entry is associated with 2 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 2 registration numbers. Click on an entry to view related FDA registrations.