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 | Arctic Front Advance, Arctic Front Advance Pro |
| Generic Name | Catheter, Percutaneous, Cardiac Ablation, For Treatment Of Atrial Fibrillation |
| Applicant | Medtronic CryoCath LP8200 Coral Sea Streetms Mvs46mounds View, MN 55112 PMA NumberP100010 Supplement NumberS128 Date Received05/20/2022 Decision Date06/01/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-20 |
| Decision Date | 2022-06-01 |
| PMA | P100010 |
| Supplement | S128 |
| 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 PMA NumberP100010 Supplement NumberS128 Date Received05/20/2022 Decision Date06/01/2022 Product Code OAE Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement to Update The FACTORYWorks Manufacturing Execution System To Release 9.10 |
| 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 |