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.
Updates to the manufacturing steps and fixtures at manufacturing station p09 y block to shaft assembly used in the manufacture of the arctic front and arctic frontadvance catheters.
| Device | ARCTIC FRONT CRYOABLATION CATHETER; ARCTIC FRONT ADVANCE CRYOABLATION CATHETER |
| Classification Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | Medtronic CryoCath LP |
| Date Received | 2014-03-05 |
| Decision Date | 2014-04-03 |
| PMA | P100010 |
| Supplement | S035 |
| Product Code | OAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic CryoCath LP 8200 Coral Sea Street ms Mvs46 mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P100010 | Original Filing | |
| S135 | 2022-12-22 | 30-day Notice |
| S134 | 2022-12-21 | 30-day Notice |
| S133 | 2022-11-14 | 30-day Notice |
| S132 | 2022-10-28 | 30-day Notice |
| S131 | ||
| S130 | 2022-08-24 | 30-day Notice |
| S129 | 2022-07-25 | 30-day Notice |
| S128 | 2022-05-20 | 30-day Notice |
| S127 | 2022-04-25 | 30-day Notice |
| S126 | 2022-02-16 | 30-day Notice |
| S125 | 2022-02-14 | 30-day Notice |
| S124 | 2021-12-21 | 30-day Notice |
| S123 | ||
| S122 | 2021-11-18 | 30-day Notice |
| S121 | 2021-11-08 | 30-day Notice |
| S120 | 2021-10-12 | 30-day Notice |
| S119 | 2021-08-09 | Real-time Process |
| S118 | ||
| S117 | 2021-07-09 | Normal 180 Day Track No User Fee |
| S116 | 2021-07-08 | Normal 180 Day Track No User Fee |
| S115 | 2021-05-04 | 30-day Notice |
| S114 | ||
| S113 | 2021-02-03 | 30-day Notice |
| S112 | 2020-11-24 | 30-day Notice |
| S111 | 2020-11-19 | 30-day Notice |
| S110 | ||
| S109 | 2020-10-21 | 30-day Notice |
| S108 | ||
| S107 | 2020-06-29 | Real-time Process |
| S106 | 2020-06-12 | 30-day Notice |
| S105 | 2020-05-20 | 30-day Notice |
| S104 | 2020-05-14 | 30-day Notice |
| S103 | 2020-02-18 | 30-day Notice |
| S102 | 2020-02-18 | 30-day Notice |
| S101 | 2020-01-27 | 30-day Notice |
| S100 | 2019-12-23 | 30-day Notice |
| S099 | 2019-11-15 | 30-day Notice |
| S098 | ||
| S097 | 2019-09-20 | 30-day Notice |
| S096 | 2019-09-12 | 30-day Notice |
| S095 | 2019-06-10 | 30-day Notice |
| S094 | 2019-05-16 | Normal 180 Day Track No User Fee |
| S093 | 2019-05-09 | Real-time Process |
| S092 | 2019-05-07 | 30-day Notice |
| S091 | 2019-04-30 | 30-day Notice |
| S090 | ||
| S089 | 2019-03-11 | 30-day Notice |
| S088 | 2019-01-30 | 30-day Notice |
| S087 | 2018-12-06 | 30-day Notice |
| S086 | 2018-11-02 | Normal 180 Day Track No User Fee |
| S085 | 2018-09-17 | 30-day Notice |
| S084 | 2018-09-17 | Normal 180 Day Track |
| S083 | 2018-08-28 | 30-day Notice |
| S082 | 2018-08-27 | 30-day Notice |
| S081 | 2018-07-09 | 30-day Notice |
| S080 | 2018-06-28 | 30-day Notice |
| S079 | 2018-06-15 | 30-day Notice |
| S078 | 2018-03-28 | 30-day Notice |
| S077 | 2018-03-27 | 30-day Notice |
| S076 | 2018-03-05 | Real-time Process |
| S075 | 2018-02-16 | 30-day Notice |
| S074 | 2018-02-08 | 30-day Notice |
| S073 | 2018-02-07 | Real-time Process |
| S072 | 2018-01-16 | 30-day Notice |
| S071 | 2017-12-11 | Real-time Process |
| S070 | 2017-11-20 | Normal 180 Day Track |
| S069 | 2017-11-17 | 30-day Notice |
| S068 | 2017-11-01 | 30-day Notice |
| S067 | 2017-07-26 | 30-day Notice |
| S066 | 2017-07-13 | Real-time Process |
| S065 | 2017-07-11 | Real-time Process |
| S064 | 2017-03-28 | 30-day Notice |
| S063 | 2017-03-21 | 30-day Notice |
| S062 | 2017-02-23 | 30-day Notice |
| S061 | 2016-12-07 | 30-day Notice |
| S060 | 2016-11-14 | Real-time Process |
| S059 | 2016-10-24 | 30-day Notice |
| S058 | 2016-07-08 | Normal 180 Day Track No User Fee |
| S057 | 2016-06-07 | 30-day Notice |
| S056 | 2016-06-07 | Real-time Process |
| S055 | ||
| S054 | 2016-04-01 | Real-time Process |
| S053 | 2016-02-10 | Real-time Process |
| S052 | 2015-12-18 | 30-day Notice |
| S051 | 2015-10-09 | 30-day Notice |
| S050 | 2015-07-28 | Special (immediate Track) |
| S049 | ||
| S048 | 2015-03-16 | Real-time Process |
| S047 | 2015-01-29 | Real-time Process |
| S046 | 2014-12-08 | Normal 180 Day Track |
| S045 | 2014-09-15 | 30-day Notice |
| S044 | 2014-09-02 | 30-day Notice |
| S043 | 2014-08-29 | 30-day Notice |
| S042 | 2014-08-05 | 30-day Notice |
| S041 | 2014-07-23 | 30-day Notice |
| S040 | 2014-06-27 | 30-day Notice |
| S039 | 2014-06-23 | Real-time Process |
| S038 | 2014-06-23 | 30-day Notice |
| S037 | 2014-06-23 | Real-time Process |
| S036 | 2014-06-03 | 30-day Notice |
| S035 | 2014-03-05 | 30-day Notice |
| S034 | 2014-01-15 | 30-day Notice |
| S033 | 2014-01-09 | 30-day Notice |
| S032 | 2013-10-16 | Normal 180 Day Track No User Fee |
| S031 | 2013-09-11 | 135 Review Track For 30-day Notice |
| S030 | 2013-06-17 | Real-time Process |
| S029 | 2013-06-04 | Real-time Process |
| S028 | 2013-05-13 | 30-day Notice |
| S027 | 2013-05-03 | 30-day Notice |
| S026 | 2013-05-03 | 135 Review Track For 30-day Notice |
| S025 | 2013-04-26 | 135 Review Track For 30-day Notice |
| S024 | 2013-04-18 | Real-time Process |
| S023 | 2013-02-22 | 30-day Notice |
| S022 | 2013-03-05 | Real-time Process |
| S021 | 2012-10-22 | 30-day Notice |
| S020 | 2012-10-01 | 30-day Notice |
| S019 | 2012-09-13 | 30-day Notice |
| S018 | 2012-07-26 | Normal 180 Day Track |
| S017 | 2012-06-26 | Real-time Process |
| S016 | 2012-03-06 | 30-day Notice |
| S015 | 2012-02-17 | Real-time Process |
| S014 | 2012-01-17 | 30-day Notice |
| S013 | 2011-12-16 | 30-day Notice |
| S012 | 2011-09-07 | 30-day Notice |
| S011 | 2011-08-18 | 30-day Notice |
| S010 | 2011-04-29 | Real-time Process |
| S009 | 2011-03-30 | 30-day Notice |
| S008 | 2011-03-25 | Real-time Process |
| S007 | 2011-02-15 | Real-time Process |
| S006 | ||
| S005 | 2011-02-11 | Real-time Process |
| S004 | 2011-02-07 | Real-time Process |
| S003 | 2011-02-03 | 30-day Notice |
| S002 | 2011-02-01 | Real-time Process |
| S001 | 2011-01-12 | Normal 180 Day Track No User Fee |