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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device pediatric esophageal atresia anastomosis device
Regulation Description Gastrointestinal tube and accessories.
Definition Lengthening atretic esophageal ends < 4cm apart and creating an anastomosis with a non-surgical procedure in pediatric patients, up to one year of age with esophageal atresia without a tracheoesophageal fistula (TEF) or in pediatric patients up to one year of age for whom a concurrent TEF has been closed as a result of a prior procedure. The procedure is performed with magnets inserted through an esophageal and gastric catheter.
Product CodePTK
Regulation Number 876.5980
Device Class 3

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