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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
Trade NameFlourish Pediatric Esophageal Atresia Anastomosis Device
Classification Namepediatric esophageal atresia anastomosis device
Generic Namepediatric esophageal atresia anastomosis device
Regulation Number876.5980
4900 bethania station rd
winston salem, NC 27105
HDE NumberH150003
Date Received12/21/2015
Decision Date05/12/2017
Product Code
Docket Number 17M-3103
Notice Date 05/17/2017
Advisory Committee Gastroenterology
Supplement Typehde original
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
Supplements: S001 S002 S003 S004 S005 S006 S007 S008