HDE supplement
H190001 S005: Plasma Delipidation System (PDS-2™ System)
FDA HDE supplement · normal 75 day track · HDL Therapeutics, Inc.
Key facts
| Original HDE | H190001 |
|---|---|
| Supplement number | S005 |
| Supplement type | normal 75 day track |
| Reason for the supplement | postapproval study protocol |
| 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 |
| Received date | Aug 4, 2023 |
| Decision date | Oct 16, 2023 |
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: