Approval for the mynx vascular closure system. The device is indicted 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, 6f, or 7f procedural sheath.
| Device | MYNX VASCULAR CLOSURE DEVICE |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ACCESS CLOSURE, INC. |
| Date Received | 2006-04-06 |
| Decision Date | 2007-05-16 |
| Notice Date | 2007-07-20 |
| PMA | P040044 |
| Supplement | S001 |
| Product Code | MGB |
| Docket Number | 07M-0285 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| 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 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
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 |
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