PMA P180011S046

Device: Eluvia Drug-Eluting Vascular Stent System
Applicant: Boston Scientific Corp
Product code: NIU
Decision date: 2021-12-23
Generic name: Stent, superficial femoral artery, drug-eluting
Approval order statement: Approval for the introduction of a 150mm length Eluvia device, reintroduction of 180mm and 200mm Innova devices, and delivery system shaft modifications.

Current openFDA PMA Record#

Device: Eluvia Drug-Eluting Vascular Stent System
Applicant: Boston Scientific Corp
PMA number: P180011
Supplement: S046
Product code: NIU
Generic name: Stent, superficial femoral artery, drug-eluting
Decision date: 2021-12-23
Decision code: APPR
Date received: 2021-10-01
Supplement type: Normal 180 Day Track
Supplement reason: Change Design/Components/Specifications/Material
Approval order statement: Approval for the introduction of a 150mm length Eluvia device, reintroduction of 180mm and 200mm Innova devices, and delivery system shaft modifications.