HDE supplement
H980006 S016: MDS NORDION THERASPHERE YTTRIUM-90 GLASS MICROSPHERES
FDA HDE supplement · special (immediate track) · Boston Scientific Corporation
Key facts
| Original HDE | H980006 |
|---|---|
| Supplement number | S016 |
| Supplement type | special (immediate track) |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | MDS NORDION THERASPHERE YTTRIUM-90 GLASS MICROSPHERES |
| Generic name | Microspheres radionuclide |
| Applicant | Boston Scientific Corporation |
| Product code | NAW |
| Received date | Apr 9, 2009 |
| Decision date | Feb 28, 2014 |
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: