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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Trade NameFlourish Pediatric Esophageal Atresia Anastomosis Device
Classification Namepediatric esophageal atresia anastomosis device
Generic Namepediatric esophageal atresia anastomosis device
Regulation Number876.5980
Applicant
WILSON-COOK MEDICAL INC.
4900 bethania station rd
winston salem, NC 27105
HDE NumberH150003
Date Received12/21/2015
Decision Date05/12/2017
Product Code
PTK
Docket Number 17M-3103
Notice Date 05/17/2017
Advisory Committee Gastroenterology
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the flourish pediatric esophageal atresia device. This device is indicated for use in lengthening atretic esophageal ends 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. This device is indicated for atretic segments < 4cm apart.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
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