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 ablation catheters which feature design changes to the performer catheter. The device, as modified, will be marked under the trade name rf enhancer 7french, 5 mm ablation catheter and is indicated for use with the medtronic rf power generator to deliver rf energy for intracardiac ablation of accessory atrioventricular (av) conduction pathways associated with tachycardia for the treatment of av nodal re-entrant tachycardia and for creation of complete av block in patients with a difficult to control ventricular response to an atrial arrhythmia.
| Device | RF ENHANCER 7 FRENCH, 5 MM ABLATION CATHETER |
| Generic Name | Cardiac Ablation Percutaneous Catheter |
| Applicant | MEDTRONIC Inc. |
| Date Received | 2002-03-18 |
| Decision Date | 2002-05-31 |
| PMA | P930029 |
| Supplement | S017 |
| Product Code | LPB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| 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 |