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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the Original HDE to get an up-to-date view of this device.
 
Trade NameFlourish Pediatric Esophageal Atresia 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
Supplement NumberS006
Date Received11/12/2020
Decision Date12/10/2020
Product Code
PTK
Advisory Committee Gastroenterology
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for labeling modifications to include enhanced recommendations for potential complications, a warning regarding the use of a 18 fr feeding/gastric tube in the lower esophageal pouch, and clarifying the locking status of the oral or gastric catheters.
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