|
Trade Name | Flourish Pediatric Atresia 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 | S001 |
Date Received | 06/16/2017 |
Decision Date | 04/27/2018 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol - osb |
Expedited Review Granted? | No |
Combination Product | No |