HDE
H980006: MDS NORDION THERASPHERE YTTRIUM-90 GLASS MICROSPHERES
FDA Humanitarian Device Exemption · Boston Scientific Corporation
Key facts
| HDE number | H980006 |
|---|---|
| Trade name | MDS NORDION THERASPHERE YTTRIUM-90 GLASS MICROSPHERES |
| Generic name | Microspheres radionuclide |
| Applicant | Boston Scientific Corporation |
| Owner/operator | Boston Scientific Corporation |
| Product code | NAW |
| Approval date | Dec 10, 1999 |
| Docket number | 99M-5539 |
| Establishment registration | 3005099803 |
| FEI number | 3005099803 |
At a glance
- 10–99 Supplements
- Jun 6, 2018 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 10–99 UDI device identifiers (GUDID)
- 100–999 MAUDE adverse event reports
- 1–9 Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE approvals
A Humanitarian Device Exemption (HDE) authorizes devices intended to benefit patients with rare diseases or conditions affecting small populations in the United States.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: