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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original HDE to get an up-to-date view of this device.
 
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
Supplement NumberS004
Date Received08/25/2022
Decision Date09/20/2022
Product Code
QNB[ Registered Establishments with QNB ]
Advisory Committee Gastroenterology
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
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.
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