HDE supplement
H960001 S003: HARRISON FETAL BLADDER STENT SET
FDA HDE supplement · normal 75 day track · Cook Incorporated
Key facts
| Original HDE | H960001 |
|---|---|
| Supplement number | S003 |
| Supplement type | normal 75 day track |
| Reason for the supplement | process change - manufacturer/sterilizer/packager/supplier |
| Trade name | HARRISON FETAL BLADDER STENT SET |
| Generic name | Stent, bladder, fetal |
| Applicant | Cook Incorporated |
| Product code | MPR |
| Received date | Nov 1, 2012 |
| Decision date | Feb 22, 2013 |
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: