Acculink Carotid Stent System

FDA Premarket Approval P040012 S060

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

New suppliers of injection molded components

DeviceAcculink Carotid Stent System
Generic NameStent, Carotid
ApplicantABBOTT VASCULAR
Date Received2020-09-08
Decision Date2020-10-06
PMAP040012
SupplementS060
Product CodeNIM 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR 3200 Lakeside Drive santa Clara, CA 95054

Supplemental Filings

Supplement NumberDateSupplement Type
P040012Original Filing
S060 2020-09-08 30-day Notice
S059 2017-03-21 30-day Notice
S058 2016-10-03 Real-time Process
S057 2016-09-26 Normal 180 Day Track No User Fee
S056 2016-01-04 Normal 180 Day Track No User Fee
S055 2015-03-09 30-day Notice
S054 2015-01-14 30-day Notice
S053 2013-11-29 135 Review Track For 30-day Notice
S052 2013-07-29 30-day Notice
S051 2012-12-19 30-day Notice
S050 2012-10-31 Real-time Process
S049 2012-08-24 30-day Notice
S048 2012-06-13 30-day Notice
S047 2012-06-11 30-day Notice
S046 2012-06-06 Normal 180 Day Track No User Fee
S045 2012-05-24 30-day Notice
S044 2012-03-20 Normal 180 Day Track
S043 2011-11-21 30-day Notice
S042 2011-09-19 Normal 180 Day Track
S041 2011-08-02 30-day Notice
S040 2011-06-10 30-day Notice
S039 2011-06-09 135 Review Track For 30-day Notice
S038 2011-02-28 30-day Notice
S037 2011-02-28 30-day Notice
S036 2011-02-18 135 Review Track For 30-day Notice
S035 2010-10-05 30-day Notice
S034 2010-10-01 Panel Track
S033 2010-09-17 30-day Notice
S032 2010-05-03 135 Review Track For 30-day Notice
S031 2009-11-02 Normal 180 Day Track
S030 2009-07-06 30-day Notice
S029 2008-12-22 30-day Notice
S028 2008-11-10 30-day Notice
S027 2007-09-27 Normal 180 Day Track No User Fee
S026 2007-04-02 30-day Notice
S025 2006-12-21 30-day Notice
S024 2006-11-14 30-day Notice
S023 2006-08-02 30-day Notice
S022 2006-07-21 30-day Notice
S021
S020 2006-07-14 135 Review Track For 30-day Notice
S019 2006-07-14 135 Review Track For 30-day Notice
S018 2006-07-10 135 Review Track For 30-day Notice
S017 2006-06-30 Special (immediate Track)
S016 2006-06-29 Special (immediate Track)
S015 2006-03-01 135 Review Track For 30-day Notice
S014 2006-02-28 30-day Notice
S013 2006-02-28 30-day Notice
S012 2006-02-28 30-day Notice
S011 2006-02-28 30-day Notice
S010 2006-02-28 Real-time Process
S009 2006-02-28 135 Review Track For 30-day Notice
S008 2006-02-24 Special (immediate Track)
S007 2006-02-24 30-day Notice
S006 2006-02-24 30-day Notice
S005 2006-02-24 30-day Notice
S004 2006-02-24 30-day Notice
S003 2005-12-22 Normal 180 Day Track No User Fee
S002
S001 2004-09-16 Normal 180 Day Track No User Fee

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