Eluvia Drug-Eluting Vascular Stent System

Stent, Superficial Femoral Artery, Drug-eluting

FDA Premarket Approval P180011

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

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.

• Device: Eluvia Drug-Eluting Vascular Stent System
• Classification Name: Stent, Superficial Femoral Artery, Drug-eluting
• Generic Name: Stent, Superficial Femoral Artery, Drug-eluting
• Applicant: Boston Scientific Corp.
• Date Received: 2018-04-13
• Decision Date: 2018-09-18
• Notice Date: 2018-09-20
• PMA: P180011
• Supplement: S
• Product Code: NIU
• Docket Number: 18M-3548
• Advisory Committee: Cardiovascular
• Expedited Review: No
• Combination Product: Yes
• Applicant Address: Boston Scientific Corp. one Scimed Place maple Grove, MN 55311
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

Supplemental Filings

Supplement Number	Date	Supplement Type
P180011		Original Filing
S051	2022-10-18	30-day Notice
S050	2022-08-08	30-day Notice
S049	2022-04-07	30-day Notice
S048	2021-11-15	30-day Notice
S047	2021-10-04	30-day Notice
S046
S045	2021-08-30	30-day Notice
S044
S043	2021-07-09	30-day Notice
S042	2021-04-13	30-day Notice
S041	2021-02-01	30-day Notice
S040	2020-12-03	30-day Notice
S039	2020-11-20	30-day Notice
S038	2020-11-09	30-day Notice
S037	2020-08-21	30-day Notice
S036
S035	2020-07-14	30-day Notice
S034
S033	2020-06-10	30-day Notice
S032	2020-06-05	30-day Notice
S031	2020-04-21	30-day Notice
S030	2020-03-27	30-day Notice
S029	2020-03-23	30-day Notice
S028
S027	2020-02-07	30-day Notice
S026	2020-01-27	30-day Notice
S025
S024
S023	2020-01-15	30-day Notice
S022	2020-01-08	30-day Notice
S021	2019-12-09	30-day Notice
S020	2019-11-21	30-day Notice
S019	2019-11-18	30-day Notice
S018	2019-11-15	30-day Notice
S017	2019-11-13	30-day Notice
S016	2019-09-30	30-day Notice
S015	2019-09-16	30-day Notice
S014	2019-08-14	30-day Notice
S013
S012	2019-09-12	30-day Notice
S011	2019-08-30	Special (immediate Track)
S010	2019-08-27	30-day Notice
S009	2019-06-27	30-day Notice
S008	2019-05-21	30-day Notice
S007	2019-05-06	30-day Notice
S006
S005	2019-03-01	30-day Notice
S004
S003	2018-11-21	30-day Notice
S002	2018-11-14	30-day Notice
S001	2018-11-06	30-day Notice

NIH GUDID Devices

Device ID	PMA	Supp
08714729876731	P180011	000
08714729876595	P180011	000
08714729876588	P180011	000
08714729876571	P180011	000
08714729876557	P180011	000
08714729876540	P180011	000
08714729876533	P180011	000
08714729876526	P180011	000
08714729876519	P180011	000
08714729876601	P180011	000
08714729876618	P180011	000
08714729876632	P180011	000
08714729876724	P180011	000
08714729876717	P180011	000
08714729876700	P180011	000
08714729876694	P180011	000
08714729876670	P180011	000
08714729876663	P180011	000
08714729876656	P180011	000
08714729876649	P180011	000
08714729876748	P180011	046
08714729876687	P180011	046
08714729876625	P180011	046
08714729876564	P180011	046