HDE
H190001: Plasma Delipidation System (PDS-2™ System)
FDA Humanitarian Device Exemption · HDL Therapeutics, Inc.
Key facts
| HDE number | H190001 |
|---|---|
| Trade name | Plasma Delipidation System (PDS-2™ System) |
| Generic name | Plasma processing system for converting alpha to pre-beta high-density lipoprotein |
| Applicant | HDL Therapeutics, Inc. |
| Product code | QNB |
| Approval date | Dec 1, 2020 |
| Docket number | 20M-2248 |
| Notice date | Dec 4, 2020 |
At a glance
- 1–9 Supplements
- Oct 16, 2023 Latest supplement decision
- Yes Summary of safety and probable benefit on file
- None UDI device identifiers (GUDID)
- None 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: