Multi-Link Vision RX Coronary Stent System, Multi-Link Mini Vision RX Coronary Stent System, Multi-Link 8/8SV/8LL Corona

FDA Premarket Approval P020047 S073

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

To change the resin of a molded component on the delivery system

DeviceMulti-Link Vision RX Coronary Stent System, Multi-Link Mini Vision RX Coronary Stent System, Multi-Link 8/8SV/8LL Corona
Generic NameStent, Coronary
ApplicantABBOTT VASCULAR
Date Received2020-08-14
Decision Date2020-09-11
PMAP020047
SupplementS073
Product CodeMAF 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR p.o. Box 9018 temecula, CA 92589-9018

Supplemental Filings

Supplement NumberDateSupplement Type
P020047Original Filing
S073 2020-08-14 30-day Notice
S072 2019-09-26 135 Review Track For 30-day Notice
S071 2019-01-24 30-day Notice
S070 2018-09-05 30-day Notice
S069 2018-06-13 30-day Notice
S068 2018-01-26 30-day Notice
S067 2017-12-11 Normal 180 Day Track No User Fee
S066 2017-09-28 135 Review Track For 30-day Notice
S065 2017-06-05 Normal 180 Day Track No User Fee
S064 2016-12-06 Normal 180 Day Track
S063 2015-09-25 30-day Notice
S062
S061 2015-01-14 30-day Notice
S060 2014-09-26 30-day Notice
S059 2014-08-27 30-day Notice
S058 2014-04-14 30-day Notice
S057 2014-03-18 30-day Notice
S056 2013-10-18 30-day Notice
S055 2013-09-30 30-day Notice
S054 2013-09-05 30-day Notice
S053 2012-11-09 30-day Notice
S052 2012-10-02 30-day Notice
S051 2012-09-28 30-day Notice
S050 2012-07-25 30-day Notice
S049 2012-07-20 30-day Notice
S048 2012-05-22 30-day Notice
S047 2012-02-28 30-day Notice
S046 2012-02-22 Normal 180 Day Track No User Fee
S045
S044 2012-01-31 30-day Notice
S043 2012-02-06 30-day Notice
S042 2012-02-03 Real-time Process
S041 2012-02-01 Normal 180 Day Track No User Fee
S040 2011-10-11 30-day Notice
S039 2011-08-30 30-day Notice
S038 2011-08-02 30-day Notice
S037 2011-07-18 30-day Notice
S036 2011-06-09 135 Review Track For 30-day Notice
S035 2011-05-09 135 Review Track For 30-day Notice
S034 2011-04-13 30-day Notice
S033 2011-03-18 30-day Notice
S032 2011-02-11 135 Review Track For 30-day Notice
S031 2011-03-04 30-day Notice
S030 2011-03-04 30-day Notice
S029 2011-02-11 135 Review Track For 30-day Notice
S028
S027 2010-11-15 30-day Notice
S026 2010-10-05 30-day Notice
S025 2010-10-01 30-day Notice
S024 2010-09-17 30-day Notice
S023 2010-09-16 135 Review Track For 30-day Notice
S022 2010-07-01 Real-time Process
S021 2010-06-23 30-day Notice
S020 2010-05-28 30-day Notice
S019 2010-04-23 30-day Notice
S018 2010-03-23 30-day Notice
S017 2009-11-02 Normal 180 Day Track
S016 2009-10-23 30-day Notice
S015 2009-06-30 30-day Notice
S014 2008-11-10 30-day Notice
S013 2008-11-05 30-day Notice
S012 2008-08-06 30-day Notice
S011 2007-10-02 30-day Notice
S010 2007-09-10 Normal 180 Day Track No User Fee
S009 2007-03-09 30-day Notice
S008 2007-01-19 30-day Notice
S007 2006-12-11 Real-time Process
S006 2006-06-12 Special (immediate Track)
S005 2006-06-05 135 Review Track For 30-day Notice
S004 2004-05-17 Normal 180 Day Track
S003 2004-04-12 Normal 180 Day Track
S002 2004-03-09 Normal 180 Day Track No User Fee
S001 2003-10-02 Special (immediate Track)

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