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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™)
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 NumberS003
Date Received09/13/2021
Decision Date12/05/2021
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 of the human factors (hf) post-approval study (pas) protocol for the post-approval study (pas) referenced above. The hf pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for h190001.
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