Approval for minor design changes to the 6f/7f mynx vascular closure device. The device, as modified, will be marketed under the trade name m5 mynx vascular closure device and is indicated for use to seal femoral arterial access sites while reducing times to hemostasis and ambulation in patients who have undergone diagnostic or interventional endovascular procedures utilizing a 5f procedural sheath.
| Device | M5 MYNX VASCULAR CLOSURE DEVICE |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ACCESS CLOSURE, INC. |
| Date Received | 2009-02-17 |
| Decision Date | 2009-04-08 |
| PMA | P040044 |
| Supplement | S011 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ACCESS CLOSURE, INC. 5452 Betsy Ross Drive santa Clara, CA 95054 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P040044 | | Original Filing |
| S093 |
2022-09-29 |
30-day Notice |
| S092 |
2022-06-02 |
30-day Notice |
| S091 |
2022-03-31 |
30-day Notice |
| S090 |
2021-11-19 |
30-day Notice |
| S089 | | |
| S088 |
2021-10-08 |
30-day Notice |
| S087 |
2021-10-07 |
30-day Notice |
| S086 |
2021-09-01 |
30-day Notice |
| S085 |
2019-09-03 |
30-day Notice |
| S084 |
2019-04-24 |
30-day Notice |
| S083 |
2019-02-12 |
30-day Notice |
| S082 |
2018-08-27 |
30-day Notice |
| S081 |
2018-05-16 |
Normal 180 Day Track No User Fee |
| S080 |
2018-04-02 |
30-day Notice |
| S079 |
2018-02-05 |
Normal 180 Day Track |
| S078 |
2017-11-20 |
Normal 180 Day Track |
| S077 |
2017-06-30 |
Real-time Process |
| S076 |
2017-05-01 |
30-day Notice |
| S075 |
2016-11-21 |
135 Review Track For 30-day Notice |
| S074 |
2016-08-29 |
30-day Notice |
| S073 |
2016-06-06 |
30-day Notice |
| S072 |
2016-04-04 |
30-day Notice |
| S071 | | |
| S070 |
2016-01-07 |
Real-time Process |
| S069 |
2016-01-05 |
30-day Notice |
| S068 |
2015-12-07 |
Normal 180 Day Track No User Fee |
| S067 | | |
| S066 |
2015-09-09 |
Real-time Process |
| S065 |
2015-07-09 |
30-day Notice |
| S064 |
2015-07-02 |
30-day Notice |
| S063 |
2015-03-25 |
30-day Notice |
| S062 |
2014-12-19 |
Real-time Process |
| S061 |
2014-12-12 |
30-day Notice |
| S060 |
2014-12-12 |
30-day Notice |
| S059 |
2014-11-12 |
Real-time Process |
| S058 |
2014-10-30 |
30-day Notice |
| S057 |
2014-05-23 |
Real-time Process |
| S056 |
2014-05-02 |
Normal 180 Day Track |
| S055 |
2014-04-10 |
30-day Notice |
| S054 |
2014-04-03 |
Real-time Process |
| S053 |
2014-04-01 |
30-day Notice |
| S052 |
2014-03-31 |
30-day Notice |
| S051 |
2014-03-31 |
30-day Notice |
| S050 |
2013-12-26 |
30-day Notice |
| S049 |
2013-08-14 |
135 Review Track For 30-day Notice |
| S048 |
2013-02-22 |
Real-time Process |
| S047 |
2012-12-31 |
Normal 180 Day Track |
| S046 |
2012-12-26 |
30-day Notice |
| S045 |
2012-11-14 |
Normal 180 Day Track No User Fee |
| S044 |
2012-11-06 |
Real-time Process |
| S043 |
2012-02-08 |
Real-time Process |
| S042 |
2011-12-13 |
30-day Notice |
| S041 |
2011-11-21 |
30-day Notice |
| S040 |
2011-11-14 |
Real-time Process |
| S039 |
2011-08-29 |
135 Review Track For 30-day Notice |
| S038 |
2011-05-27 |
Normal 180 Day Track No User Fee |
| S037 |
2011-03-10 |
Real-time Process |
| S036 |
2011-02-10 |
30-day Notice |
| S035 | | |
| S034 |
2010-09-30 |
Normal 180 Day Track |
| S033 |
2010-08-18 |
Real-time Process |
| S032 |
2010-05-20 |
Special (immediate Track) |
| S031 |
2010-04-02 |
30-day Notice |
| S030 |
2010-04-01 |
30-day Notice |
| S029 |
2010-03-29 |
30-day Notice |
| S028 |
2010-03-04 |
30-day Notice |
| S027 |
2010-02-22 |
Special (immediate Track) |
| S026 |
2010-02-19 |
30-day Notice |
| S025 |
2010-02-12 |
135 Review Track For 30-day Notice |
| S024 |
2009-12-14 |
30-day Notice |
| S023 |
2009-10-29 |
30-day Notice |
| S022 |
2009-10-27 |
30-day Notice |
| S021 |
2009-10-23 |
Real-time Process |
| S020 |
2009-10-22 |
30-day Notice |
| S019 |
2009-09-30 |
30-day Notice |
| S018 | | |
| S017 |
2009-07-21 |
30-day Notice |
| S016 |
2009-07-15 |
Real-time Process |
| S015 |
2009-06-25 |
Special (immediate Track) |
| S014 |
2009-04-14 |
Special (immediate Track) |
| S013 |
2009-04-13 |
30-day Notice |
| S012 |
2009-03-19 |
Special (immediate Track) |
| S011 |
2009-02-17 |
Real-time Process |
| S010 |
2008-11-13 |
Real-time Process |
| S009 |
2008-06-04 |
30-day Notice |
| S008 |
2008-06-03 |
Real-time Process |
| S007 |
2008-03-31 |
Normal 180 Day Track No User Fee |
| S006 |
2008-03-14 |
Special (immediate Track) |
| S005 |
2008-03-11 |
135 Review Track For 30-day Notice |
| S004 |
2007-11-16 |
Special (immediate Track) |
| S003 |
2007-10-05 |
30-day Notice |
| S002 |
2007-08-24 |
Special (immediate Track) |
| S001 |
2006-04-06 |
Panel Track |
NIH GUDID Devices