Approval for clarification and simplification of the language used inthe instruction for use and removal of the sterilization indicator label from the device pouch for the mynx cadence vascular closure device, 6f/7f mynxgrip vascular closure device, and 5f mynxgrip vascular closure device.
| Device | MYNXCADENCE AND MYNXGRIP VASCULAR DEVICES |
| Classification Name | Device, Hemostasis, Vascular |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | ACCESS CLOSURE, INC. |
| Date Received | 2013-02-22 |
| Decision Date | 2013-05-17 |
| PMA | P040044 |
| Supplement | S048 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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