NIU · Stent, Superficial Femoral Artery, Drug-Eluting
· Class 3
Overview
| Product Code | NIU |
|---|---|
| Device Name | Stent, Superficial Femoral Artery, Drug-Eluting |
| Device Class | Class 3 |
| Review Panel | |
| Implant | Yes |
| Life-Sustaining | Yes |
Identification
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.
Recent Cleared Devices (2 of 2)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P180011 | Eluvia Drug-Eluting Vascular Stent System | Boston Scientific Corp | Sep 18, 2018 | APPR |
| P100022 | ZILVER PTX DRUG-ELUTING PERIPHERAL STENT | Cook Ireland, Ltd. | Nov 14, 2012 | APPR |
Top Applicants
- Boston Scientific Corp — 1 clearance
- Cook Ireland, Ltd. — 1 clearance
