Eluvia Drug-Eluting Vascular Stent System

FDA premarket approval P180011 · Stent, superficial femoral artery, drug-eluting

PMA numberP180011

Approval

Applicant
Boston Scientific Corp
Received
April 13, 2018
Decision date
September 18, 2018 (APPR)
Supplements
67, latest August 21, 2026
Product code
NIU – Stent, Superficial Femoral Artery, Drug-Eluting

Official FDA PMA record

Approval order statement

Approval for the ELUVIA Drug-Eluting Vascular Stent System. The device is indicated for improving luminal diameter in the treatment of symptomatic de-novo or restenotic lesions in the native superficial femoral artery (SFA) and/or proximal popliteal artery with reference vessel diameters (RVD) ranging from 4.0 - 6.0 mm and total lesion lengths up to 190 mm.