Eluvia Drug-Eluting Vascular Stent System

FDA Premarket Approval P180011 S022

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

Modification of incoming raw material testing and specifications for pvdf-hfp

DeviceEluvia Drug-Eluting Vascular Stent System
Generic NameStent, Superficial Femoral Artery, Drug-eluting
ApplicantBoston Scientific Corp.
Date Received2020-01-08
Decision Date2020-02-06
PMAP180011
SupplementS022
Product CodeNIU 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address Boston Scientific Corp. one Scimed Place maple Grove, MN 55311

Supplemental Filings

Supplement NumberDateSupplement Type
P180011Original Filing
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

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