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 to change the supplier of the polyethylene terephthlate (pet) alloy balloon tubing used in the manufacturing of the devices.
| Device | NEPTUNE X-ACT/NEPTUNE X-ACT OTW BALLOON DILATATION CATHETER |
| Generic Name | Catheters, Transluminal Coronary Angioplasty, Percutaneous |
| Applicant | MEDTRONIC IRELAND |
| Date Received | 2000-08-28 |
| Decision Date | 2001-12-21 |
| PMA | P790017 |
| Supplement | S073 |
| Product Code | LOX |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location 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 |