Product code QNB

Device name

Plasma Processing System For Converting Alpha To Pre-Beta High-Density Lipoprotein

Medical specialty

Unknown

Device class

f

Review panel

GU

Implant

N

Life sustaining/supporting

N

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

To reduce coronary atheroma in patients with Homozygous Familial Hypercholesterolemia.

Source

FDA openFDA device classification dataset