LifeStent 5F Vascular Stent Systems

FDA Premarket Approval P070014 S062

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

A new supplier and manufacturing processes for delivery system handle components

DeviceLifeStent 5F Vascular Stent Systems
Generic NameStent, Superficial Femoral Artery
Date Received2021-05-04
Decision Date2021-06-03
Product CodeNIP 
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
P070014Original Filing
S062 2021-05-04 30-day Notice
S061 2020-08-31 30-day Notice
S058 2018-08-20 Special (immediate Track)
S057 2018-07-23 30-day Notice
S056 2018-06-05 30-day Notice
S055 2018-06-01 Real-time Process
S054 2017-09-21 30-day Notice
S053 2017-08-29 Normal 180 Day Track
S052 2016-09-30 30-day Notice
S051 2016-07-01 Normal 180 Day Track No User Fee
S049 2015-11-10 30-day Notice
S048 2015-11-04 Normal 180 Day Track
S047 2014-10-27 Normal 180 Day Track
S046 2014-05-20 30-day Notice
S045 2014-05-12 Normal 180 Day Track No User Fee
S044 2014-05-01 Normal 180 Day Track
S043 2014-03-24 30-day Notice
S042 2014-02-25 30-day Notice
S041 2013-12-24 Special (immediate Track)
S040 2013-08-28 30-day Notice
S039 2013-06-14 30-day Notice
S038 2013-03-29 30-day Notice
S037 2012-12-28 Panel Track
S036 2012-11-09 Normal 180 Day Track No User Fee
S035 2012-10-22 30-day Notice
S034 2012-08-22 30-day Notice
S033 2012-08-15 Special (immediate Track)
S032 2012-04-06 Real-time Process
S031 2012-04-02 30-day Notice
S030 2012-02-01 135 Review Track For 30-day Notice
S029 2011-10-28 30-day Notice
S028 2011-10-21 30-day Notice
S027 2011-10-03 Real-time Process
S026 2011-09-26 Special (immediate Track)
S025 2011-09-21 Normal 180 Day Track No User Fee
S024 2011-09-08 30-day Notice
S023 2011-05-20 Normal 180 Day Track No User Fee
S022 2011-03-10 Normal 180 Day Track
S020 2010-12-13 Normal 180 Day Track No User Fee
S019 2010-09-28 30-day Notice
S018 2010-09-09 Normal 180 Day Track No User Fee
S017 2010-06-01 30-day Notice
S016 2010-05-28 30-day Notice
S015 2010-05-26 30-day Notice
S014 2010-04-13 Normal 180 Day Track
S013 2010-03-22 135 Review Track For 30-day Notice
S012 2010-03-19 135 Review Track For 30-day Notice
S011 2010-03-16 30-day Notice
S010 2010-03-10 Panel Track
S009 2010-01-29 135 Review Track For 30-day Notice
S008 2009-12-23 135 Review Track For 30-day Notice
S007 2009-12-14 Normal 180 Day Track No User Fee
S006 2009-11-20 Special (immediate Track)
S005 2009-10-30 30-day Notice
S004 2009-09-08 30-day Notice
S003 2009-08-04 30-day Notice
S002 2009-06-18 30-day Notice
S001 2009-06-02 Real-time Process

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