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Trade Name | Flourish Pediatric Esophageal Atresia Device |
Classification Name | pediatric esophageal atresia anastomosis device |
Generic Name | pediatric esophageal atresia anastomosis device |
Regulation Number | 876.5980 |
Applicant |
WILSON-COOK MEDICAL INC. |
4900 bethania station rd |
winston salem, NC 27105 |
|
HDE Number | H150003 |
Supplement Number | S006 |
Date Received | 11/12/2020 |
Decision Date | 12/10/2020 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | special (immediate track) |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
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. |