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.
| Device | MYNX Vascular Closure |
| Generic Name | Device, Hemostasis, Vascular |
| Applicant | Cordis US Corporation14201 Nw 60th Avenuemiami Lakes, FL 33014 PMA NumberP040044 Supplement NumberS091 Date Received03/31/2022 Decision Date04/25/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-04-25 |
| PMA | P040044 |
| Supplement | S091 |
| Product Code | MGB |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Cordis US Corporation 14201 Nw 60th Avenue miami Lakes, FL 33014 PMA NumberP040044 Supplement NumberS091 Date Received03/31/2022 Decision Date04/25/2022 Product Code MGB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement the Addition Of An Alternate Supplier For Components Of The MYNX® Vascular Closure Device (VCD) |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 20862028000417 | P040044 | 000 |
| 20862028000400 | P040044 | 000 |
| 10862028000427 | P040044 | 000 |
| 10862028000434 | P040044 | 000 |
| M465MX67210 | P040044 | 040 |
| M465MX50210 | P040044 | 043 |
| M465MX67400 | P040044 | 047 |
| 20705032090275 | P040044 | 097 |