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.
To update the manufacturing execution system (mes) to factoryworks (fw) release 9. 9
| Device | RF Conductr, RF Contactr, RF Enhancr II, RF Marinr, RF Unipolar Marinr |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2021-11-18 |
| Decision Date | 2021-12-07 |
| PMA | P930029 |
| Supplement | S070 |
| 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 Inc. 8200 Coral Sea Street Ne ms Mv S11 mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930029 | Original Filing | |
| S071 | 2022-05-20 | 30-day Notice |
| S070 | 2021-11-18 | 30-day Notice |
| S069 | 2020-11-27 | 30-day Notice |
| S068 | 2020-11-24 | 30-day Notice |
| S067 | 2020-08-31 | 30-day Notice |
| S066 | 2020-07-02 | 30-day Notice |
| S065 | 2018-12-20 | Normal 180 Day Track |
| S064 | 2018-12-07 | 30-day Notice |
| S063 | 2018-11-19 | 30-day Notice |
| S062 | ||
| S061 | 2018-08-30 | 30-day Notice |
| S060 | 2018-06-01 | 30-day Notice |
| S059 | 2018-02-22 | 30-day Notice |
| S058 | 2018-01-16 | Real-time Process |
| S057 | 2016-11-14 | 30-day Notice |
| S056 | ||
| S055 | 2016-08-03 | Real-time Process |
| S054 | 2015-12-28 | 30-day Notice |
| S053 | 2015-08-05 | 30-day Notice |
| S052 | 2015-07-23 | Normal 180 Day Track No User Fee |
| S051 | 2015-04-17 | 30-day Notice |
| S050 | 2015-03-27 | 30-day Notice |
| S049 | 2014-12-24 | Real-time Process |
| S048 | 2014-12-23 | Real-time Process |
| S047 | 2014-12-18 | Real-time Process |
| S046 | 2014-08-27 | 30-day Notice |
| S045 | ||
| S044 | 2014-07-01 | Real-time Process |
| S043 | 2014-05-05 | 30-day Notice |
| S042 | 2014-02-27 | 30-day Notice |
| S041 | 2014-02-11 | 30-day Notice |
| S040 | 2013-12-19 | 30-day Notice |
| S039 | 2013-03-22 | 30-day Notice |
| S038 | 2012-11-30 | 30-day Notice |
| S037 | 2012-11-21 | 30-day Notice |
| S036 | 2012-02-29 | 30-day Notice |
| S035 | 2011-11-25 | 30-day Notice |
| S034 | 2011-10-21 | 30-day Notice |
| S033 | 2011-07-18 | 30-day Notice |
| S032 | 2011-07-08 | 30-day Notice |
| S031 | 2011-06-08 | 30-day Notice |
| S030 | 2011-05-13 | 30-day Notice |
| S029 | 2011-04-26 | 30-day Notice |
| S028 | 2010-11-12 | 30-day Notice |
| S027 | 2010-10-26 | 30-day Notice |
| S026 | ||
| S025 | 2010-07-15 | 30-day Notice |
| S024 | 2010-07-15 | 30-day Notice |
| S023 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S022 | 2009-05-11 | 30-day Notice |
| S021 | 2003-12-10 | Real-time Process |
| S020 | 2003-02-14 | Real-time Process |
| S019 | 2002-12-16 | Special (immediate Track) |
| S018 | 2002-11-04 | Real-time Process |
| S017 | 2002-03-18 | Real-time Process |
| S016 | ||
| S015 | 2001-08-06 | Real-time Process |
| S014 | 2000-06-28 | Real-time Process |
| S013 | 2000-02-29 | Normal 180 Day Track |
| S012 | 1998-06-30 | Normal 180 Day Track |
| S011 | 1998-03-23 | Normal 180 Day Track |
| S010 | 1997-11-04 | Normal 180 Day Track |
| S009 | ||
| S008 | 1996-12-26 | Normal 180 Day Track |
| S007 | 1996-03-15 | Normal 180 Day Track |
| S006 | 1995-11-03 | Normal 180 Day Track |
| S005 | 1995-09-25 | Normal 180 Day Track |
| S004 | 1995-08-30 | Special (immediate Track) |
| S003 | 1995-04-14 | Special (immediate Track) |
| S002 | 1995-03-20 | Normal 180 Day Track |
| S001 | 1995-02-15 | Normal 180 Day Track |