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Eluvia Drug-Eluting Vascular Stent System

FDA premarket approval P180011 · decided 2018-09-18

Approval details

PMA number
P180011
Trade name
Eluvia Drug-Eluting Vascular Stent System
Generic name
Stent, superficial femoral artery, drug-eluting
Applicant
Boston Scientific Corp
Date received
2018-04-13
Decision date
2018-09-18
Days to decision
158 days
Decision code
APPR
Product code
NIU
Advisory committee
Cardiovascular
Expedited review
No
Location
Maple Grove, MN
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.

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