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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device esophageal protection device for use in percutaneous cardiac catheter ablation procedures, mechanical deviation
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 mechanical means to deviate the esophagus away from the source of ablation energy
Product CodeQXU
Regulation Number 870.5710
Device Class 2


Premarket Reviews
ManufacturerDecision
S4 MEDICAL CORP
  GRANTED 1

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