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 | RF Conductr, RF Enhancr II, RF Marinr, RF Unipolar Marinr |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | MEDTRONIC Inc.8200 Coral Sea Street Nems Mv S11mounds View, MN 55112 PMA NumberP930029 Supplement NumberS071 Date Received05/20/2022 Decision Date06/01/2022 Product Code LPB Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-05-20 |
| Decision Date | 2022-06-01 |
| PMA | P930029 |
| Supplement | S071 |
| 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 PMA NumberP930029 Supplement NumberS071 Date Received05/20/2022 Decision Date06/01/2022 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 to Update The FACTORYWorks Manufacturing Execution System To Release 9.10 |
| 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 |