TECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM

FDA Premarket Approval P960043 S016

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 modifications to the instructions for use to include an alternative surgical knot.

DeviceTECHSTAR XL AND PROSTAR XL PERCUTANEOUS VASCULAR SURGICAL SYSTEM
ApplicantABBOTT VASCULAR INC.
Date Received1999-01-08
Decision Date1999-05-28
PMAP960043
SupplementS016
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. 400 Saginaw Drive redwood City, CA 94063

Supplemental Filings

Supplement NumberDateSupplement Type
P960043Original Filing
S120 2022-11-21 135 Review Track For 30-day Notice
S119 2022-11-16 30-day Notice
S118
S117 2022-07-25 30-day Notice
S116 2022-06-15 30-day Notice
S115 2021-09-27 30-day Notice
S114 2021-08-23 30-day Notice
S113 2021-08-09 30-day Notice
S112
S111 2021-01-29 30-day Notice
S110 2020-11-05 30-day Notice
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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