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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 NumberS001
Date Received12/30/2020
Decision Date10/04/2021
Product Code
QNB[ Registered Establishments with QNB ]
Advisory Committee Gastroenterology
Clinical Trials NCT03135184
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the halo-fh protocol for the post-approval study.
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