|
Trade Name | Plasma Delipidation System (PDS-2™ System) |
Classification Name | plasma processing system for converting alpha to pre-beta high-density lipoprotein |
Generic Name | plasma 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 Number | H190001 |
Supplement Number | S004 |
Date Received | 08/25/2022 |
Decision Date | 09/20/2022 |
Product Code | |
Advisory Committee |
Gastroenterology |
Supplement Type | normal 75 day track |
Supplement Reason | postapproval study protocol |
Expedited Review Granted? | No |
Combination Product | No |
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. |