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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 |
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HDE Number | H150003 |
Supplement Number | S007 |
Date Received | 11/02/2021 |
Decision Date | 12/01/2021 |
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; 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. |