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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)

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Trade NamePlasma Delipidation System (PDS-2™ System)
Classification Nameplasma processing system for converting alpha to pre-beta high-density lipoprotein
Generic Nameplasma processing system for converting alpha to pre-beta high-density lipoprotein
Applicant
HDL Therapeutics, Inc.
601 21st street, suite 300
vero beach, FL 32960
HDE NumberH190001
Date Received01/08/2019
Decision Date12/01/2020
Product Code
QNB[ Registered Establishments with QNB ]
Docket Number 20M-2248
Notice Date 12/04/2020
Advisory Committee Gastroenterology
Clinical Trials NCT03135184
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the plasma delipidation system (pds-2™). This device is indicated to reduce coronary artery atheroma in adult patients with homozygous familial hypercholesterolemia (hofh) who are either inadequately responsive to or intolerant of maximal therapy for hofh, including the latest medications and other device therapies approved by the fda.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
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