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U.S. Department of Health and Human Services

Product Classification

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Device drug eluting permanent left ventricular (lv) pacemaker electrode
Definition Drug eluting permanent lv pacemaker electrodes are used with compatible cardiac rhythm therapy (crt) devices to deliver pacing pulses to the heart.
Physical State The device is a flexible, insulated electrical conductor with one end designed to make a secure connection to a CRT device and the other end located in a left cardiac vein.
Technical Method Used as part of an implantable crt system.
Target Area Makes contact with the lv via the left cardiac vein.
Review Panel Cardiovascular
Product CodeOJX
Premarket Review Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Cardiac Electrophysiology, Diagnostics, and Monitoring Devices (DHT2A)
Submission Type PMA
Device Class 3
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Implanted Device? Yes
Life-Sustain/Support Device? Yes
Recognized Consensus Standards
Third Party Review Not Third Party Eligible