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 r2l rapid exchange and d2l over-the-wire balloon dilatation catheters with extended pressure range. The devices are indicated for balloon dilatation of the stenotic portion of a coronary artery or bypass graft stenosis for the purpose of improving myocardial perfusion.
| Device | R2L RAPID EXCHANGE BALLOON DILATATION CATHETER WITH EXTENDED PRESSURE RANGE AND D2L OVER-THE-WIRE BALLOON DILATATION CAT |
| Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MEDTRONIC IRELAND |
| Date Received | 2001-03-29 |
| Decision Date | 2001-06-01 |
| PMA | P790017 |
| Supplement | S075 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | MEDTRONIC IRELAND parkmore Business Park West galway |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P790017 | Original Filing | |
| S110 | 2010-10-01 | 30-day Notice |
| S109 | 2010-08-16 | 30-day Notice |
| S108 | 2010-06-04 | 30-day Notice |
| S107 | 2010-03-22 | 30-day Notice |
| S106 | 2010-03-16 | 135 Review Track For 30-day Notice |
| S105 | ||
| S104 | 2009-12-24 | 135 Review Track For 30-day Notice |
| S103 | 2009-11-19 | 30-day Notice |
| S102 | 2009-11-09 | Normal 180 Day Track No User Fee |
| S101 | 2009-10-13 | 30-day Notice |
| S100 | 2009-01-26 | Normal 180 Day Track No User Fee |
| S099 | 2008-12-16 | 30-day Notice |
| S098 | 2008-11-05 | Normal 180 Day Track No User Fee |
| S097 | 2008-05-01 | Normal 180 Day Track No User Fee |
| S096 | 2008-03-31 | Normal 180 Day Track |
| S095 | 2008-03-31 | Normal 180 Day Track |
| S094 | 2008-03-24 | 135 Review Track For 30-day Notice |
| S093 | 2007-11-13 | 30-day Notice |
| S092 | 2007-08-01 | 30-day Notice |
| S091 | 2007-08-01 | 30-day Notice |
| S090 | ||
| S089 | ||
| S088 | 2007-07-30 | 30-day Notice |
| S087 | 2007-07-23 | 30-day Notice |
| S086 | 2006-12-04 | 135 Review Track For 30-day Notice |
| S085 | 2006-04-17 | Special (immediate Track) |
| S084 | 2005-09-23 | 30-day Notice |
| S083 | 2004-12-10 | Real-time Process |
| S082 | 2004-04-05 | Real-time Process |
| S081 | 2003-12-26 | Real-time Process |
| S080 | 2003-04-30 | 30-day Notice |
| S079 | 2003-01-16 | Real-time Process |
| S078 | 2002-12-18 | Normal 180 Day Track |
| S077 | 2002-04-01 | Normal 180 Day Track |
| S076 | 2001-11-05 | Normal 180 Day Track |
| S075 | 2001-03-29 | Real-time Process |
| S074 | 2000-09-14 | Real-time Process |
| S073 | 2000-08-28 | Normal 180 Day Track |
| S072 | 2000-07-14 | 30-day Notice |
| S071 | 2000-03-01 | Normal 180 Day Track |
| S070 | ||
| S069 | 1998-12-01 | Normal 180 Day Track |
| S068 | 1998-12-10 | 30-day Notice |
| S067 | 1998-03-23 | Normal 180 Day Track |
| S066 | 1998-04-01 | Real-time Process |
| S065 | 1998-02-12 | Real-time Process |
| S064 | 1998-01-20 | Real-time Process |
| S063 | 1997-07-31 | Real-time Process |
| S062 | 1997-05-30 | Normal 180 Day Track |
| S061 | 1997-01-27 | Real-time Process |
| S060 | 1996-12-17 | Normal 180 Day Track |
| S059 | 1996-02-28 | Normal 180 Day Track |
| S058 | 1995-10-03 | Normal 180 Day Track |
| S057 | 1995-09-20 | Normal 180 Day Track |
| S056 | 1995-04-10 | 30-Day Supplement |
| S055 | ||
| S054 | ||
| S053 | ||
| S052 | 1993-06-23 | Normal 180 Day Track |
| S051 | ||
| S050 | ||
| S049 | 1992-12-23 | Normal 180 Day Track |
| S048 | ||
| S047 | 1992-07-22 | Normal 180 Day Track |
| S046 | 1992-06-29 | Normal 180 Day Track |
| S045 | 1991-04-03 | Normal 180 Day Track |
| S044 | 1992-03-03 | Normal 180 Day Track |
| S043 | 1992-01-13 | Normal 180 Day Track |
| S042 | ||
| S041 | 1991-11-19 | Normal 180 Day Track |
| S040 | 1991-02-21 | Normal 180 Day Track |
| S039 | 1991-01-11 | Normal 180 Day Track |
| S038 | ||
| S037 | ||
| S036 | ||
| S035 | ||
| S034 | ||
| S033 | ||
| S032 | ||
| S031 | 1989-07-18 | Normal 180 Day Track |
| S030 | ||
| S029 | ||
| S028 | 1989-05-26 | Normal 180 Day Track |
| S027 | 1989-04-21 | Normal 180 Day Track |
| S026 | 1989-04-06 | Normal 180 Day Track |
| S025 | 1988-11-14 | Normal 180 Day Track |
| S024 | ||
| S023 | ||
| S022 | 1988-08-29 | Normal 180 Day Track |
| S021 | 1988-03-31 | Special (immediate Track) |
| S020 | 1988-03-11 | Normal 180 Day Track |
| S019 | 1988-01-22 | Normal 180 Day Track |
| S018 | 1987-12-22 | Normal 180 Day Track |
| S017 | 1987-11-18 | Normal 180 Day Track |
| S016 | 1987-10-23 | Normal 180 Day Track |
| S015 | 1987-07-15 | Normal 180 Day Track |
| S014 | ||
| S013 | 1987-02-02 | Normal 180 Day Track |
| S012 | 1986-10-03 | Normal 180 Day Track |
| S011 | 1985-06-14 | |
| S010 | ||
| S009 | 1984-01-19 | |
| S008 | 1983-10-12 | Normal 180 Day Track |
| S007 | 1983-07-22 | |
| S006 | 1982-11-05 | |
| S005 | 1982-10-25 | |
| S004 | 1982-05-18 | |
| S003 | 1981-08-04 | |
| S002 | 1981-08-04 | |
| S001 | 1980-12-22 | Normal 180 Day Track |