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 revised labeling
| Device | USCI GRUNTZIG DILACA CORONARY ARTERY BALLOON DILATATION CATHETER & USCI XPRT WITH PRO/PEL COATING BALLOON DILATATION |
| Classification Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MEDTRONIC IRELAND |
| Date Received | 1995-09-20 |
| Decision Date | 1996-01-25 |
| PMA | P790017 |
| Supplement | S057 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |