Product code NIU

Device name

Stent, Superficial Femoral Artery, Drug-Eluting

Medical specialty

Unknown

Device class

3

Review panel

CV

Implant

Y

Life sustaining/supporting

Y

GMP exempt

N

Third party review

N

Summary malfunction reporting

Ineligible

Definition

Stent, Superficial Femoral Artery, Drug-Eluting -- a metal scaffold with a drug coating placed via a delivery catheter into the superficial femoral artery artery to maintain the lumen. The drug coating is intended to inhibit restenosis.

Source

FDA openFDA device classification dataset