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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device esophageal dilator balloon with or without electrode sensors
Regulation Description Gastrointestinal tube and accessories.
Definition To dilate the lower esophageal sphincter of patients with Achalasia.
Product CodePID
Regulation Number 876.5980
Device Class 2


Premarket Reviews
ManufacturerDecision
BOSTON SCIENTIFIC CORP.
  SUBSTANTIALLY EQUIVALENT 1

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