Perclose ProGlide Suture-Mediated Closure System

FDA Premarket Approval P960043 S109

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

The proposed automation of an existing manual inspection process through the introduction of alternate automated test equipment for the subject device

DevicePerclose ProGlide Suture-Mediated Closure System
Generic NameDevice, Hemostasis, Vascular
ApplicantABBOTT VASCULAR INC.
Date Received2020-09-04
Decision Date2020-10-01
PMAP960043
SupplementS109
Product CodeMGB 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address ABBOTT VASCULAR INC. 400 Saginaw Drive redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P960043Original Filing
S109 2020-09-04 30-day Notice
S108 2020-07-13 30-day Notice
S107
S106 2019-07-26 30-day Notice
S105 2019-07-01 30-day Notice
S104 2019-04-24 30-day Notice
S103 2018-11-29 30-day Notice
S102 2018-11-13 Normal 180 Day Track No User Fee
S101 2018-07-20 Real-time Process
S100 2018-04-02 30-day Notice
S099 2017-11-16 30-day Notice
S098 2017-10-05 30-day Notice
S097 2017-07-28 Panel Track
S096 2017-01-17 30-day Notice
S095 2016-11-21 30-day Notice
S094 2016-11-09 30-day Notice
S093 2016-06-09 30-day Notice
S092 2016-04-28 30-day Notice
S091 2015-11-09 Normal 180 Day Track No User Fee
S090 2015-05-18 Normal 180 Day Track No User Fee
S089 2014-11-17 Real-time Process
S088 2014-03-18 30-day Notice
S087 2014-02-19 30-day Notice
S086 2014-01-03 30-day Notice
S085 2013-12-31 30-day Notice
S084 2013-08-26 30-day Notice
S083 2013-07-18 135 Review Track For 30-day Notice
S082 2013-07-01 Real-time Process
S081
S080 2012-07-20 Panel Track
S079 2012-04-04 30-day Notice
S078 2012-04-03 30-day Notice
S077 2012-03-16 30-day Notice
S076 2011-10-24 30-day Notice
S075 2011-07-25 Real-time Process
S074 2011-07-18 30-day Notice
S073 2011-06-30 Real-time Process
S072 2010-12-06 30-day Notice
S071 2010-04-06 30-day Notice
S070 2009-11-27 30-day Notice
S069 2009-10-22 30-day Notice
S068 2009-10-05 30-day Notice
S067 2009-09-22 30-day Notice
S066 2009-08-04 30-day Notice
S065 2009-05-28 Normal 180 Day Track No User Fee
S064 2008-08-15 30-day Notice
S063 2008-04-16 Real-time Process
S062 2007-10-23 30-day Notice
S061 2007-10-23 30-day Notice
S060 2006-10-20 Special (immediate Track)
S059 2006-07-06 Special (immediate Track)
S058 2005-10-12 Special (immediate Track)
S057 2005-07-11 Special (immediate Track)
S056 2004-08-05 Real-time Process
S055 2004-07-08 Special (immediate Track)
S054 2004-07-02 Real-time Process
S053 2004-03-15 Special (immediate Track)
S052 2004-02-17 Real-time Process
S051
S050
S049 2003-10-27 Special (immediate Track)
S048 2003-09-08 Normal 180 Day Track No User Fee
S047 2003-07-08 Real-time Process
S046 2003-06-17 Normal 180 Day Track
S045 2003-04-18 Special (immediate Track)
S044 2003-03-03 Real-time Process
S043 2002-11-18 Real-time Process
S042 2002-10-08 Real-time Process
S041 2002-07-26 Normal 180 Day Track
S040 2002-04-26 Real-time Process
S039 2002-04-17 Real-time Process
S038 2002-03-26 Real-time Process
S037 2002-01-14 30-day Notice
S036 2001-12-21 Normal 180 Day Track
S035 2001-11-19 Real-time Process
S034
S033 2001-09-12 135 Review Track For 30-day Notice
S032 2001-07-26 Real-time Process
S031 2001-01-29 Normal 180 Day Track
S030 2000-12-26 Real-time Process
S029 2000-11-29 Normal 180 Day Track
S028 2000-11-13 30-day Notice
S027 2000-09-13 Real-time Process
S026 2000-08-31 Real-time Process
S025 2000-07-03 Real-time Process
S024 2000-04-04 Normal 180 Day Track
S023 2000-04-04 Normal 180 Day Track
S022 2000-03-23 Normal 180 Day Track
S021 1999-11-30 Normal 180 Day Track
S020 1999-07-23 Special (immediate Track)
S019 1999-05-03 Normal 180 Day Track
S018 1999-04-22 Special (immediate Track)
S017 1999-04-02 Special (immediate Track)
S016 1999-01-08 Normal 180 Day Track
S015 1998-12-17 Normal 180 Day Track
S014 1998-11-16 Special (immediate Track)
S013 1998-11-12 Normal 180 Day Track
S012 1998-10-19 Normal 180 Day Track
S011 1998-10-02 Normal 180 Day Track
S010 1998-08-03 Normal 180 Day Track
S009 1998-07-21 Normal 180 Day Track
S008 1998-06-22 Special (immediate Track)
S007 1998-04-15 Normal 180 Day Track
S006 1998-03-13 Normal 180 Day Track
S005 1998-03-09 Normal 180 Day Track
S004
S003 1997-10-02 Special (immediate Track)
S002 1997-06-02 Normal 180 Day Track
S001 1997-05-01 Normal 180 Day Track

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