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 manufacturing and material design changes, i. E. , changing to a press-fit handle, to a green and white suture, to an internal suture storage, changing the thumb cap/plunger attachment back to what was previously approved in p960043/s036, and a change in the o-ring material. In addition, the labeling is being modified to include other healthcare professionals in the precaution on the limitation of use to physicians who have been trained in the use of this device. The device, as modified, will be marketed under the trade name closer ak 6fr. Suture-mediated closure (smc) system and is indicated for the percutaneous delivery of suture for closing the common femoral artery access site of patients who have undergone diagnostic or interventional catheterization procedures using 5 to 6 fr. Sheaths. The closer 6 fr. Smc systems reduce the times to hemostasis, ambulation (10 feet) and discharge in patients who have undergone diagnostic and interventional catheterization procedures without complicating clinical conditions (refer to precautions, special patient populations).
| Device | THE CLOSER AK 6 FR. SMC DEVICE |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2002-04-17 |
| Decision Date | 2002-05-21 |
| PMA | P960043 |
| Supplement | S039 |
| Product Code | MGB |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| 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 |