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U.S. Department of Health and Human Services

Product Classification
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Device leadless cardiac resynchronization therapy (crt)
Definition Leadless Cardiac Resynchronization Therapy (CRT) is intended to deliver CRT using a leadless left ventricular implant
Physical State leadless electrode, transmitter, battery, delivery catheter, programmer
Technical Method delivery to the left ventricular endocardium
Target Area left ventricle
Review Panel Cardiovascular
Product CodeSEG
Premarket Review Office of Cardiovascular Devices (OHT2)
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
Reporting		 Ineligible
Implanted Device? Yes
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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