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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 NumberS008
Date Received10/07/2022
Decision Date11/03/2022
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 further enhance the safety of the device, including potential complications of tissue erosion, magnet migration, and pleural effusion; added a contraindication for patients who cannot be intubated or administered sedative or paralytic drugs during the device indwelling period. Expanded the procedure preparation steps and the instructions for use step 9 to clarify that patients may be intubated, sedated, and administered paralytic drugs to minimize movement during device placement or indwell period at the physician’s discretion.
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