This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the prostar(r) percutaneous vascular surgical (pvs) system. The prostar(r) pvs system consists of the prostar(r) pvs device (9 and 11 french sizes) and the following accessories: a prostar(r) pre-dilator (9 and 11 french sizes), a perclose(r) knot pusher, and prostar(r) transition guidewire, and a perclose(r) arterial tamper. The prostar(r) pvs system is indicated for the percutaneous delivery of sutures for closing the common femoral artery access site anc reducing the time to hemostasis and ambulation (time-to-standing) of patients who have undergone interventional procedures using 8 to 11 french sheaths
| Device | PROSTAR 9 FR. PERCUTANEOUS VASCULAR SURGICAL (PVS) SYSTEM |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 1996-11-26 |
| Decision Date | 1997-04-30 |
| Notice Date | 1997-07-08 |
| PMA | P960043 |
| Supplement | S |
| Product Code | MGB |
| Docket Number | 97M-0274 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 400 Saginaw Drive redwood City, CA 94063 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960043 | Original 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 |