NIU
- Product code
- NIU
- Device name
- Stent, Superficial Femoral Artery, Drug-Eluting
- Device class
- Class 3
- Medical specialty
- Unknown
- Marketing pathway
- PMA
- Flag
- Implant
- Flag
- Life-sustaining / life-supporting
FDA classification 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.
Official FDA classification page: NIU
Classification and pathway per current FDA publications. Data from openFDA (CC0).