MULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM

Stent, Coronary

FDA Premarket Approval P020047 S004

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

Approval for the 2. 75 mm line extension for the multi-link vision coronary stent system. The device is indicated for improving coronary luminal diameter in patients with abrupt or threatened abrupt closure with failed interventional therapy of de novo and restenotic native coronary artery lesions (length

DeviceMULTI-LINK VISION CORONARY STENT SYSTEM - 2.75 MM
Classification NameStent, Coronary
Generic NameStent, Coronary
ApplicantABBOTT VASCULAR
Date Received2004-05-17
Decision Date2004-09-10
PMAP020047
SupplementS004
Product CodeMAF
Docket NumberPremarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration   Follow FDA En Español Search FDA   Home Food Drugs Medical Devices Radia
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR p.o. Box 9018 temecula, CA 92589-9018

Supplemental Filings

Supplement NumberDateSupplement Type
P020047Original Filing
S075 2022-08-09 30-day Notice
S074 2021-02-22 30-day Notice
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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