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.
Approval for the perclose proglide smc system which is indicated for the percutaneous delivery of suture for closing the common femoral artery and vein access site of patients who have undergone diagnostic or interventional catheterization procedures. The perclose proglide smc system is used without or, if required, with adjunctive manual compression. 1) for access sites in the common femoral artery using 5f to 21f sheaths. For sheath sizes greater than 8f, at least two devices and the pre-close technique are required; and2) for access sites in the common femoral vein using 5f to 24f sheaths.
| Device | Perclose ProGlide Suture-Mediated Closure System |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2017-07-28 |
| Decision Date | 2018-02-16 |
| Notice Date | 2018-02-21 |
| PMA | P960043 |
| Supplement | S097 |
| Product Code | MGB |
| Docket Number | 18M-0792 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 400 Saginaw Drive redwood City, CA 94063 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Approval Order: | Approval Order |
| 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 |