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 | Livewire TC Ablation Catheter |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | St. Jude Medical14900 Minnetonka Ind Rdminnetonka, MN 55345 PMA NumberP960016 Supplement NumberS089 Date Received11/14/2022 Decision Date12/08/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-14 |
| Decision Date | 2022-12-08 |
| PMA | P960016 |
| Supplement | S089 |
| 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 | St. Jude Medical 14900 Minnetonka Ind Rd minnetonka, MN 55345 PMA NumberP960016 Supplement NumberS089 Date Received11/14/2022 Decision Date12/08/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement an Alternate Tier 3 Supplier Of Resin For The FlexAbility/FlexAbility SE Ablation Catheters, TactiCath SE Ablation Catheter, Livewire TC Ablation Catheter, And Safire Ablation Catheter |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P960016 | Original Filing | |
| S089 | 2022-11-14 | 30-day Notice |
| S088 | 2021-09-14 | 30-day Notice |
| S087 | ||
| S086 | 2021-01-13 | Real-time Process |
| S085 | 2020-09-18 | 30-day Notice |
| S084 | ||
| S083 | 2020-05-06 | 30-day Notice |
| S082 | 2020-03-23 | 30-day Notice |
| S081 | 2020-03-19 | 30-day Notice |
| S080 | 2019-09-26 | 30-day Notice |
| S079 | 2019-06-24 | Normal 180 Day Track No User Fee |
| S078 | 2019-04-26 | 30-day Notice |
| S077 | 2019-02-14 | Normal 180 Day Track No User Fee |
| S076 | 2018-12-12 | Special (immediate Track) |
| S075 | 2018-08-02 | 30-day Notice |
| S074 | 2018-03-05 | 30-day Notice |
| S073 | 2018-03-01 | 30-day Notice |
| S072 | 2018-02-12 | 30-day Notice |
| S071 | 2018-02-05 | 30-day Notice |
| S070 | 2017-10-19 | 30-day Notice |
| S069 | ||
| S068 | 2017-05-04 | 30-day Notice |
| S067 | 2016-08-12 | 30-day Notice |
| S066 | 2016-06-01 | 30-day Notice |
| S065 | 2016-04-21 | 30-day Notice |
| S064 | 2016-03-22 | 135 Review Track For 30-day Notice |
| S063 | 2016-03-14 | 30-day Notice |
| S062 | 2016-03-09 | 30-day Notice |
| S061 | 2016-02-19 | 30-day Notice |
| S060 | 2015-11-20 | Real-time Process |
| S059 | 2015-10-30 | Normal 180 Day Track No User Fee |
| S058 | 2015-10-19 | 30-day Notice |
| S057 | 2015-09-23 | 30-day Notice |
| S056 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S055 | 2015-06-25 | Normal 180 Day Track |
| S054 | 2015-04-17 | 30-day Notice |
| S053 | 2015-03-06 | 30-day Notice |
| S052 | 2014-12-22 | Special (immediate Track) |
| S051 | 2014-12-17 | Real-time Process |
| S050 | 2014-11-07 | Real-time Process |
| S049 | 2014-08-27 | Real-time Process |
| S048 | 2014-08-06 | Special (immediate Track) |
| S047 | 2014-07-01 | Real-time Process |
| S046 | 2014-04-30 | Normal 180 Day Track No User Fee |
| S045 | 2014-03-03 | Real-time Process |
| S044 | 2013-11-27 | Normal 180 Day Track |
| S043 | 2013-09-19 | 135 Review Track For 30-day Notice |
| S042 | 2013-02-04 | 135 Review Track For 30-day Notice |
| S041 | 2013-02-01 | 135 Review Track For 30-day Notice |
| S040 | 2012-12-17 | Real-time Process |
| S039 | 2012-07-23 | Real-time Process |
| S038 | 2011-11-22 | 30-day Notice |
| S037 | 2011-07-05 | 30-day Notice |
| S036 | 2010-11-10 | 30-day Notice |
| S035 | 2010-10-05 | 30-day Notice |
| S034 | 2010-09-30 | Real-time Process |
| S033 | 2010-09-27 | Real-time Process |
| S032 | 2010-08-12 | 30-day Notice |
| S031 | 2010-07-20 | 30-day Notice |
| S030 | 2010-07-14 | 30-day Notice |
| S029 | 2010-05-27 | Special (immediate Track) |
| S028 | 2010-03-09 | 30-day Notice |
| S027 | 2009-10-30 | 30-day Notice |
| S026 | 2009-10-29 | 30-day Notice |
| S025 | 2009-10-28 | 30-day Notice |
| S024 | 2009-09-02 | 30-day Notice |
| S023 | ||
| S022 | 2008-01-28 | Real-time Process |
| S021 | ||
| S020 | 2007-10-03 | Real-time Process |
| S019 | 2007-08-07 | Real-time Process |
| S018 | 2007-04-26 | Real-time Process |
| S017 | ||
| S016 | 2006-04-07 | Real-time Process |
| S015 | ||
| S014 | 2005-09-09 | Normal 180 Day Track |
| S013 | 2003-09-10 | Special (immediate Track) |
| S012 | 2003-07-15 | Real-time Process |
| S011 | 2003-06-26 | 135 Review Track For 30-day Notice |
| S010 | 2003-03-05 | Normal 180 Day Track |
| S009 | 2003-02-12 | Real-time Process |
| S008 | 2002-08-08 | Real-time Process |
| S007 | 2001-05-14 | Normal 180 Day Track |
| S006 | 2000-08-22 | Normal 180 Day Track |
| S005 | 2000-08-18 | Normal 180 Day Track |
| S004 | 2000-03-30 | Normal 180 Day Track |
| S003 | 1999-06-28 | Normal 180 Day Track |
| S002 | 1999-05-20 | Normal 180 Day Track |
| S001 | 1999-05-06 | Real-time Process |
| Device ID | PMA | Supp |
|---|---|---|
| 05414734200226 | P960016 | 002 |
| 05414734217323 | P960016 | 002 |
| 05414734200257 | P960016 | 002 |
| 05414734200240 | P960016 | 002 |
| 05414734200233 | P960016 | 002 |
| 05414734200271 | P960016 | 006 |
| 05414734200288 | P960016 | 006 |
| 05414734200295 | P960016 | 006 |
| 05414734200325 | P960016 | 007 |
| 05414734200318 | P960016 | 007 |
| 05414734200301 | P960016 | 007 |
| 05414734205979 | P960016 | 014 |
| 05414734205986 | P960016 | 014 |
| 05414734205993 | P960016 | 014 |
| 05414734206006 | P960016 | 014 |
| 05414734206013 | P960016 | 014 |
| 05414734206020 | P960016 | 014 |
| 05414734217415 | P960016 | 014 |
| 05414734217385 | P960016 | 014 |
| 05414734217378 | P960016 | 014 |
| 05414734206082 | P960016 | 014 |
| 05414734206075 | P960016 | 014 |
| 05414734206068 | P960016 | 014 |
| 05414734206051 | P960016 | 014 |
| 05414734206044 | P960016 | 014 |
| 05414734206037 | P960016 | 014 |
| 05414734217422 | P960016 | 014 |
| 05414734217439 | P960016 | 016 |
| 05414734217446 | P960016 | 016 |
| 05414734217347 | P960016 | 022 |