MULTI-LINK RX ULTRA CORONARY STENT SYSTEMS

Stent, Coronary

FDA Premarket Approval P970020 S082

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 update to device labeling.

DeviceMULTI-LINK RX ULTRA CORONARY STENT SYSTEMS
Classification NameStent, Coronary
Generic NameStent, Coronary
ApplicantABBOTT VASCULAR INC.
Date Received2016-12-06
Decision Date2017-03-21
PMAP970020
SupplementS082
Product CodeMAF
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonLabeling Change - Indications/instructions/shelf Life/tradename
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR INC. 26531 Ynez Road temecula, CA 92591

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

NIH GUDID Devices

Device IDPMASupp
08717648035494 P970020 021
08717648035272 P970020 021
08717648035289 P970020 021
08717648035296 P970020 021
08717648035302 P970020 021
08717648035319 P970020 021
08717648035326 P970020 021
08717648035333 P970020 021
08717648035425 P970020 021
08717648035432 P970020 021
08717648035449 P970020 021
08717648035456 P970020 021
08717648035463 P970020 021
08717648035470 P970020 021
08717648035487 P970020 021
08717648035265 P970020 021

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