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.
Approval for the freezor xtra cardiac cryoablation catheter, cryoconsole system, and related accessories. The device is indicated for the cryoablation of the conducting tissues of the heart in the treatment of patients with atrioventricular nodal reentrant tachycardia (avnrt). The freezor xtra catheter is also intended for minimally invasive cardiac surgery procedures, including surgical treatment of cardiac arrhythmias. The freezor xtra catheter freezes the target tissue and blocks the electrical conduction by creating an inflammatory response or cryonecrosis.
| Device | FREEZOR XTRA SURGICAL CARDIAC CRYOABLATION DEVICE |
| Classification Name | Cardiac Ablation Percutaneous Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | Medtronic CryoCath LP |
| Date Received | 2016-01-28 |
| Decision Date | 2016-08-31 |
| Notice Date | 2016-09-09 |
| PMA | P020045 |
| Supplement | S073 |
| Product Code | LPB |
| Docket Number | 16M-2649 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic CryoCath LP 8200 Coral Sea Street mounds View, MN 55112 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Approval Order: | Approval Order |
| 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 |