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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 NumberS007
Date Received11/02/2021
Decision Date12/01/2021
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; warnings that the flourish device should be used only at institutions with pediatric thoracic surgery capabilities as well as capabilities in catheter and wire guide manipulation; endoscopy and bronchoscopy techniques; collection and interpretation of relevant radiographic imaging; respiratory support; nutrition and hydration; and esophageal dilatation. Also, instructions that applying sustained force to the catheter in an effort to improve magnet advancement may increase the risk of perforation or tracheoesophageal fistula.
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