BARD E-LUMINEXX VASCULAR STENT

Stent, Iliac

FDA Premarket Approval P080007

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 bard e. Luminexx vasular stent. The device is indicated for the treatment f iliac occlusive disease in patients with symptomatic vascular disease of the common and/or external iliac arteries up to 126 mm in length, with a reference vessel diameter of 5 to 9 mm.

DeviceBARD E-LUMINEXX VASCULAR STENT
Classification NameStent, Iliac
Generic NameStent, Iliac
ApplicantBARD PERIPHERAL VASCULAR, INC.
Date Received2008-03-21
Decision Date2008-12-04
Notice Date2008-12-19
PMAP080007
SupplementS
Product CodeNIO
Docket Number08M-0645
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address BARD PERIPHERAL VASCULAR, INC. 1415 West 3rd St. tempe, AZ 85281
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P080007Original Filing
S027 2022-05-02 30-day Notice
S026 2021-08-26 Real-time Process
S025 2021-07-09 30-day Notice
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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