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U.S. Department of Health and Human Services

Product Classification

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Device acute coronary syndrome event detector
Definition Detect Acute Coronary Syndrome events and prompt the patient to seek medical attention.
Physical State Hermetically sealed electronics with a flexible lead for intracardiac placement
Technical Method Monitoring the intracardiac electrogram for ST-segment deviation indicative of coronary artery occlusion.
Target Area Heart
Review Panel Cardiovascular
Product CodeQBI
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? No
Third Party Review Not Third Party Eligible