Bard E-Luminexx Vascular Stent

FDA Premarket Approval P080007 S024

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

The addition of a new laser for welding radiopaque markers to the stent

DeviceBard E-Luminexx Vascular Stent
Generic NameStent, Iliac
ApplicantBARD PERIPHERAL VASCULAR, INC.
Date Received2021-02-25
Decision Date2021-03-23
PMAP080007
SupplementS024
Product CodeNIO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address BARD PERIPHERAL VASCULAR, INC. 1415 West 3rd St. tempe, AZ 85281

Supplemental Filings

Supplement NumberDateSupplement Type
P080007Original Filing
S024 2021-02-25 30-day Notice
S023 2020-05-01 30-day Notice
S022 2019-06-18 30-day Notice
S021 2017-12-15 30-day Notice
S020 2014-03-24 30-day Notice
S019 2013-12-24 Special (immediate Track)
S018 2013-08-19 30-day Notice
S017 2013-06-04 30-day Notice
S016 2013-03-29 30-day Notice
S015 2012-11-09 Normal 180 Day Track No User Fee
S014 2012-05-21 30-day Notice
S013 2012-04-02 30-day Notice
S012
S011 2012-02-01 135 Review Track For 30-day Notice
S010 2011-11-14 30-day Notice
S009 2011-10-28 30-day Notice
S008 2011-10-21 30-day Notice
S007 2011-09-26 Real-time Process
S006
S005 2011-03-11 135 Review Track For 30-day Notice
S004 2010-08-12 30-day Notice
S003 2010-03-19 135 Review Track For 30-day Notice
S002
S001 2009-01-28 30-day Notice

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