ELUVIA Drug-Eluting Vascular Stent System

FDA Premarket Approval P180011 S049

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

DeviceELUVIA Drug-Eluting Vascular Stent System
Generic NameStent, Superficial Femoral Artery, Drug-eluting
ApplicantBoston Scientific Corp.one Scimed Placemaple Grove, MN 55311 PMA NumberP180011 Supplement NumberS049 Date Received04/07/2022 Decision Date05/06/2022 Product Code NIU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-04-07
Decision Date2022-05-06
PMAP180011
SupplementS049
Product CodeNIU 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductYes
Applicant AddressBoston Scientific Corp.
one Scimed Place
maple Grove, MN 55311 PMA NumberP180011 Supplement NumberS049 Date Received04/07/2022 Decision Date05/06/2022 Product Code NIU  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductYes Approval Order Statement  
to Process Devices Using The Reduced EtO S756 Sterilization Cycle At The BSC Coventry Rhode Island, BSC Galway Ireland, And Steris Tullamore Ireland Facilities

Supplemental Filings

Supplement NumberDateSupplement Type
P180011Original Filing
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
08714729876601 P180011 000
08714729876595 P180011 000
08714729876588 P180011 000
08714729876571 P180011 000
08714729876557 P180011 000
08714729876540 P180011 000
08714729876533 P180011 000
08714729876526 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
08714729876519 P180011 000

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