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.

DeviceEluvia Drug-Eluting Vascular Stent System
Classification NameStent, Superficial Femoral Artery, Drug-eluting
Generic NameStent, Superficial Femoral Artery, Drug-eluting
ApplicantBoston Scientific Corp.
Date Received2018-04-13
Decision Date2018-09-18
Notice Date2018-09-20
PMAP180011
SupplementS
Product CodeNIU
Docket Number18M-3548
Advisory CommitteeCardiovascular
Expedited ReviewNo
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 NumberDateSupplement Type
P180011Original 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 IDPMASupp
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.