OVJ — Pulse Generator, External Pacemaker, Dual Chamber Class II
FDA product code OVJ covers "Pulse Generator, External Pacemaker, Dual Chamber", a Class II medical device regulated under 21 CFR 870.3600. Submissions are reviewed by the Cardiovascular panel.
Classification Details
- Product Code
- OVJ
- Device Class
- Class II
- Regulation Number
- 870.3600
- Submission Type
- Review Panel
- CV
- Medical Specialty
- Cardiovascular
- Implant
- No
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.