LifeStent 5F Vascular Stent Systems

FDA Premarket Approval P070014 S061

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

An alternate supplier of delivery system handle lock marking and thermoplastic staking processes

DeviceLifeStent 5F Vascular Stent Systems
Generic NameStent, Superficial Femoral Artery
ApplicantBARD PERIPHERAL VASCULAR, INC.
Date Received2020-08-31
Decision Date2020-09-25
PMAP070014
SupplementS061
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
S061 2020-08-31 30-day Notice
S060
S059
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
S050
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
S021
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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