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.
The 30-day notice requested to modify the sterilization parameters to address the excessively long ethylene oxide residue quarantine times by reducing as exposure minor modifications to the sterilization parameters are also being introduced to improve efficiency and increase flexibility at the contract sterilization facility.
| Device | OVER THE WIRE DILATATION CATHETERS |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MEDTRONIC IRELAND |
| Date Received | 1998-12-10 |
| Decision Date | 1999-01-08 |
| PMA | P790017 |
| Supplement | S068 |
| Product Code | LOX |
| 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 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 |