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U.S. Department of Health and Human Services

Product Classification
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Device plasma processing system for converting alpha to pre-beta high-density lipoprotein
Definition To reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia.
Physical State Automated plasma processing system, system accessories, and solutions.
Technical Method Off-line plasma processing system that mixes blood plasma with delipidation solutions for converting alpha to pre-beta high-density lipoprotein.
Target Area Blood plasma.
Review Panel Gastroenterology/Urology
Product CodeQNB
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type HDE - Humanitarian Device Exemption
Device Class HDE
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Ineligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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