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.
Addition of an inspection procedure for the low pressure regulator during manufacturing, as well as the replacement of an analog pressure gauge used during installation and maintenance with a digital one.
| Device | FOCAL CATHETERS |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | Medtronic CryoCath LP |
| Date Received | 2014-06-23 |
| Decision Date | 2014-07-09 |
| PMA | P020045 |
| Supplement | S056 |
| Product Code | LPB |
| 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 mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P020045 | Original Filing | |
| S102 | 2022-12-22 | 30-day Notice |
| S101 | 2022-07-25 | 30-day Notice |
| S100 | 2022-02-16 | 30-day Notice |
| S099 | 2021-07-19 | Real-time Process |
| S098 | ||
| S097 | ||
| S096 | 2021-05-03 | 30-day Notice |
| S095 | ||
| S094 | 2021-02-23 | 30-day Notice |
| S093 | 2020-01-27 | 30-day Notice |
| S092 | ||
| S091 | ||
| S090 | 2019-09-13 | 30-day Notice |
| S089 | 2018-07-17 | 30-day Notice |
| S088 | 2018-06-15 | 30-day Notice |
| S087 | 2018-03-05 | Real-time Process |
| S086 | 2018-02-07 | Real-time Process |
| S085 | 2018-01-16 | 30-day Notice |
| S084 | 2017-11-01 | 30-day Notice |
| S083 | 2017-07-11 | Real-time Process |
| S082 | 2017-03-21 | 30-day Notice |
| S081 | 2017-02-23 | 30-day Notice |
| S080 | 2017-02-21 | 30-day Notice |
| S079 | ||
| S078 | 2016-11-14 | Real-time Process |
| S077 | 2016-10-24 | 30-day Notice |
| S076 | 2016-06-07 | 30-day Notice |
| S075 | 2016-06-07 | Real-time Process |
| S074 | 2016-02-10 | Real-time Process |
| S073 | 2016-01-28 | Panel Track |
| S072 | 2015-12-28 | 30-day Notice |
| S071 | 2015-12-28 | 30-day Notice |
| S070 | 2015-12-18 | 30-day Notice |
| S069 | 2015-12-11 | Special (immediate Track) |
| S068 | 2015-10-09 | 30-day Notice |
| S067 | 2015-07-21 | Real-time Process |
| S066 | 2015-03-16 | Real-time Process |
| S065 | 2015-01-29 | Real-time Process |
| S064 | 2014-10-16 | Normal 180 Day Track |
| S063 | 2014-09-15 | 30-day Notice |
| S062 | 2014-09-02 | 30-day Notice |
| S061 | 2014-08-29 | 30-day Notice |
| S060 | 2014-08-11 | Real-time Process |
| S059 | 2014-07-31 | Real-time Process |
| S058 | 2014-06-27 | 30-day Notice |
| S057 | 2014-06-23 | Real-time Process |
| S056 | 2014-06-23 | 30-day Notice |
| S055 | 2014-06-23 | Real-time Process |
| S054 | 2014-06-03 | Real-time Process |
| S053 | 2014-04-22 | 30-day Notice |
| S052 | 2014-01-15 | 30-day Notice |
| S051 | 2014-01-09 | 30-day Notice |
| S050 | 2013-07-29 | Normal 180 Day Track No User Fee |
| S049 | 2013-06-04 | Real-time Process |
| S048 | 2013-05-24 | 30-day Notice |
| S047 | 2013-05-03 | 30-day Notice |
| S046 | 2013-02-15 | Normal 180 Day Track No User Fee |
| S045 | 2012-07-26 | Real-time Process |
| S044 | 2012-06-26 | Real-time Process |
| S043 | 2012-05-16 | 30-day Notice |
| S042 | 2012-02-23 | Real-time Process |
| S041 | 2011-12-16 | 30-day Notice |
| S040 | 2011-09-07 | 30-day Notice |
| S039 | 2011-08-18 | 30-day Notice |
| S038 | 2011-03-30 | 30-day Notice |
| S037 | 2011-03-25 | Real-time Process |
| S036 | 2011-02-15 | 30-day Notice |
| S035 | 2010-10-20 | Real-time Process |
| S034 | 2010-08-20 | 30-day Notice |
| S033 | ||
| S032 | ||
| S031 | ||
| S030 | ||
| S029 | 2010-03-15 | Normal 180 Day Track No User Fee |
| S028 | 2010-03-08 | 135 Review Track For 30-day Notice |
| S027 | 2009-03-17 | 30-day Notice |
| S026 | 2009-03-09 | Normal 180 Day Track |
| S025 | 2008-08-19 | Special (immediate Track) |
| S024 | ||
| S023 | ||
| S022 | 2007-05-31 | 30-day Notice |
| S021 | 2007-01-09 | Real-time Process |
| S020 | ||
| S019 | 2006-05-16 | 30-day Notice |
| S018 | ||
| S017 | 2006-03-14 | 30-day Notice |
| S016 | 2006-03-15 | Real-time Process |
| S015 | 2006-02-15 | 135 Review Track For 30-day Notice |
| S014 | 2005-12-20 | Real-time Process |
| S013 | ||
| S012 | 2005-10-13 | Special (immediate Track) |
| S011 | 2005-07-21 | Special (immediate Track) |
| S010 | 2005-06-16 | Real-time Process |
| S009 | 2005-06-09 | Special (immediate Track) |
| S008 | 2005-06-06 | Special (immediate Track) |
| S007 | 2005-02-14 | Real-time Process |
| S006 | 2004-05-10 | Real-time Process |
| S005 | 2004-05-10 | Real-time Process |
| S004 | 2004-03-22 | Real-time Process |
| S003 | 2003-12-29 | Real-time Process |
| S002 | 2003-09-15 | Real-time Process |
| S001 | 2003-06-05 | Normal 180 Day Track No User Fee |