HDE supplement
H980006 S034: TheraSphere
FDA HDE supplement · normal 75 day track · Boston Scientific Corporation
Key facts
| Original HDE | H980006 |
|---|---|
| Supplement number | S034 |
| Supplement type | normal 75 day track |
| Reason for the supplement | location change - manufacturer/sterilizer/packager/supplier |
| Trade name | TheraSphere |
| Generic name | Microspheres radionuclide |
| Applicant | Boston Scientific Corporation |
| Product code | NAW |
| Received date | Oct 5, 2016 |
| Decision date | Dec 12, 2016 |
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: