Bard E- Luminexx Vascular Stent System

FDA Premarket Approval P080007 S027

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

DeviceBard E- Luminexx Vascular Stent System
Generic NameStent, Iliac
ApplicantBARD PERIPHERAL VASCULAR, INC.1415 West 3rd St.tempe, AZ 85281 PMA NumberP080007 Supplement NumberS027 Date Received05/02/2022 Decision Date05/26/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-05-02
Decision Date2022-05-26
PMAP080007
SupplementS027
Product CodeNIO 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressBARD PERIPHERAL VASCULAR, INC.
1415 West 3rd St.
tempe, AZ 85281 PMA NumberP080007 Supplement NumberS027 Date Received05/02/2022 Decision Date05/26/2022 Product Code NIO  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
an Alternative Supplier For Injection Molded Components On The Delivery System

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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