HDE
H190003: Sonalleve MR-HIFU
FDA Humanitarian Device Exemption · Profound Medical Inc.
Key facts
| HDE number | H190003 |
|---|---|
| Trade name | Sonalleve MR-HIFU |
| Generic name | Ablation system, high intensity focused ultrasound (hifu), mr guided, orthopedic |
| Applicant | Profound Medical Inc. |
| Owner/operator | Profound Medical Inc. |
| Product code | QND |
| Approval date | Nov 27, 2020 |
| Docket number | 20M-2238 |
| Notice date | Nov 27, 2020 |
| Establishment registration | 3012604011 |
| FEI number | 3012604011 |
At a glance
- None Supplements
- Nov 27, 2020 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- 1–9 UDI device identifiers (GUDID)
- 1–9 MAUDE adverse event reports
- None 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: