HDE supplement
H970001 S001: KCH Fetal Bladder Drainage Catheter
FDA HDE supplement · normal 75 day track · ROCKET MEDICAL PLC
Key facts
| Original HDE | H970001 |
|---|---|
| Supplement number | S001 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | KCH Fetal Bladder Drainage Catheter |
| Generic name | Stent, bladder, fetal |
| Applicant | ROCKET MEDICAL PLC |
| Product code | MPR |
| Received date | Dec 11, 2017 |
| Decision date | Feb 16, 2018 |
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: