HDE supplement
H150003 S004: Flourish Pediatric Esophageal Atresia Device
FDA HDE supplement · normal 75 day track · WILSON-COOK MEDICAL INC.
Key facts
| Original HDE | H150003 |
|---|---|
| Supplement number | S004 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | Flourish Pediatric Esophageal Atresia Device |
| Generic name | Pediatric esophageal atresia anastomosis device |
| Applicant | WILSON-COOK MEDICAL INC. |
| Product code | PTK |
| Received date | Aug 12, 2019 |
| Decision date | Oct 25, 2019 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: