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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device temperature regulation device for esophageal protection during cardiac ablation
Definition This device is placed in the lumen of the esophagus to reduce the likelihood of esophageal injury or a specific adverse event during cardiac ablation procedures. The device uses temperature regulation to control the temperature of the esophagus during cardiac ablation.
Product CodeQXV
Regulation Number 870.5720
Device Class 2


Premarket Reviews
ManufacturerDecision
ADVANCED COOLING THERAPY, INC. D/B/A ATTUNE MEDICAL
  GRANTED 1

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