MULTI-LINK RX ULTRA™ Coronary Stent System

FDA Premarket Approval P970020 S086

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

DeviceMULTI-LINK RX ULTRA™ Coronary Stent System
Generic NameStent, Coronary
ApplicantABBOTT VASCULAR INC.26531 Ynez Roadtemecula, CA 92591 PMA NumberP970020 Supplement NumberS086 Date Received08/09/2022 Decision Date09/07/2022 Product Code MAF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No
Date Received2022-08-09
Decision Date2022-09-07
PMAP970020
SupplementS086
Product CodeMAF 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination ProductNo
Applicant AddressABBOTT VASCULAR INC.
26531 Ynez Road
temecula, CA 92591 PMA NumberP970020 Supplement NumberS086 Date Received08/09/2022 Decision Date09/07/2022 Product Code MAF  Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement  
for The Addition Of Secondary Sterilization Equipment

Supplemental Filings

Supplement NumberDateSupplement Type
P970020Original Filing
S086 2022-08-09 30-day Notice
S085 2021-04-29 30-day Notice
S084 2019-11-15 30-day Notice
S083 2018-06-13 30-day Notice
S082 2016-12-06 Normal 180 Day Track
S081 2015-01-14 30-day Notice
S080 2014-04-14 30-day Notice
S079 2014-03-10 30-day Notice
S078 2013-10-18 30-day Notice
S077 2013-06-06 135 Review Track For 30-day Notice
S076 2012-10-02 30-day Notice
S075 2012-09-28 30-day Notice
S074 2012-07-20 30-day Notice
S073 2012-02-28 30-day Notice
S072
S071 2012-02-06 30-day Notice
S070 2012-02-01 Normal 180 Day Track No User Fee
S069 2011-10-11 30-day Notice
S068 2011-08-30 30-day Notice
S067 2011-08-02 30-day Notice
S066 2011-07-18 30-day Notice
S065 2011-06-09 135 Review Track For 30-day Notice
S064 2011-05-09 135 Review Track For 30-day Notice
S063 2011-04-14 30-day Notice
S062 2011-03-18 30-day Notice
S061 2011-03-04 30-day Notice
S060
S059 2010-11-15 30-day Notice
S058 2010-10-05 30-day Notice
S057 2010-09-17 30-day Notice
S056 2010-06-23 30-day Notice
S055 2010-03-23 30-day Notice
S054 2008-11-10 30-day Notice
S053 2008-11-05 30-day Notice
S052 2008-08-06 30-day Notice
S051 2007-11-02 30-day Notice
S050 2007-10-02 30-day Notice
S049 2007-09-24 30-day Notice
S048 2007-01-19 30-day Notice
S047 2006-06-12 Special (immediate Track)
S046 2005-01-27 Real-time Process
S045 2004-03-09 Normal 180 Day Track No User Fee
S044 2003-05-13 Normal 180 Day Track
S043 2003-02-19 Normal 180 Day Track No User Fee
S042 2002-03-19 Normal 180 Day Track
S041 2002-02-15 Normal 180 Day Track
S040 2001-12-26 Panel Track
S039 2001-11-27 Normal 180 Day Track
S038 2001-11-23 Normal 180 Day Track
S037 2001-10-12 Normal 180 Day Track
S036 2001-08-07 Real-time Process
S035 2001-08-06 Real-time Process
S034 2001-07-16 30-day Notice
S033 2001-05-07 Real-time Process
S032 2001-04-26 30-day Notice
S031 2001-04-11 Real-time Process
S030 2001-02-05 Real-time Process
S029 2001-01-25 30-day Notice
S028 2001-01-25 Normal 180 Day Track
S027 2001-01-16 Real-time Process
S026 2000-11-06 30-day Notice
S025
S024 2000-05-30 Real-time Process
S023 2000-04-12 Normal 180 Day Track
S022 2000-04-06 Normal 180 Day Track
S021 2000-03-17 Normal 180 Day Track
S020 2000-02-23 30-day Notice
S019 1999-12-06 30-day Notice
S018 1999-07-14 30-day Notice
S017 1999-06-21 Normal 180 Day Track
S016
S015 1999-04-27 30-day Notice
S014 1999-04-16 30-day Notice
S013
S012 1999-03-29 30-day Notice
S011 1999-02-26 Normal 180 Day Track
S010
S009 1998-12-28 Special (immediate Track)
S008 1998-12-28 30-day Notice
S007 1998-12-08 Normal 180 Day Track
S006 1998-10-19 30-day Notice
S005 1998-08-17 Normal 180 Day Track
S004 1998-05-14 Normal 180 Day Track
S003 1998-05-11 Normal 180 Day Track
S002 1998-02-24 Normal 180 Day Track
S001 1998-02-03 Normal 180 Day Track

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