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.
Change in the manufacturing process to obtain an alternate supplier for components used with the amplatzer septal occluder and delivery exchange systems.
| Device | AMPLATZER SEPTAL OCCLUDER AND AMPLATZER 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS |
| Classification Name | Occluder, Patent Ductus, Arteriosus |
| Generic Name | Occluder, Patent Ductus, Arteriosus |
| Applicant | Abbott Medical |
| Date Received | 2002-12-16 |
| Decision Date | 2003-01-15 |
| PMA | P000039 |
| Supplement | S003 |
| Product Code | MAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 5050 Nathan Lane North plymouth, MN 55442 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P000039 | Original Filing | |
| S076 | 2021-11-22 | Real-time Process |
| S075 | 2021-08-24 | 30-day Notice |
| S074 | 2021-06-28 | 30-day Notice |
| S073 | 2020-05-06 | 30-day Notice |
| S072 | 2020-04-24 | 30-day Notice |
| S071 | ||
| S070 | 2020-03-19 | 30-day Notice |
| S069 | 2020-03-17 | 30-day Notice |
| S068 | 2019-09-26 | 30-day Notice |
| S067 | 2019-06-24 | Normal 180 Day Track No User Fee |
| S066 | 2019-03-22 | 30-day Notice |
| S065 | 2019-02-27 | 30-day Notice |
| S064 | 2019-02-15 | Normal 180 Day Track No User Fee |
| S063 | 2019-01-03 | 30-day Notice |
| S062 | 2018-02-12 | 30-day Notice |
| S061 | 2017-11-28 | 30-day Notice |
| S060 | 2017-10-30 | Normal 180 Day Track No User Fee |
| S059 | ||
| S058 | 2017-07-06 | 30-day Notice |
| S057 | 2017-01-26 | 30-day Notice |
| S056 | 2016-07-01 | 30-day Notice |
| S055 | 2016-04-06 | 30-day Notice |
| S054 | 2016-03-14 | 30-day Notice |
| S053 | 2015-10-30 | Normal 180 Day Track No User Fee |
| S052 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S051 | 2015-08-10 | Normal 180 Day Track No User Fee |
| S050 | 2015-03-13 | Normal 180 Day Track No User Fee |
| S049 | 2013-02-19 | 135 Review Track For 30-day Notice |
| S048 | 2013-02-06 | Normal 180 Day Track |
| S047 | 2012-11-30 | Special (immediate Track) |
| S046 | 2012-05-14 | 30-day Notice |
| S045 | 2012-04-24 | 30-day Notice |
| S044 | ||
| S043 | 2011-12-29 | Special (immediate Track) |
| S042 | 2011-09-20 | 30-day Notice |
| S041 | 2011-03-09 | 30-day Notice |
| S040 | ||
| S039 | 2011-01-19 | 30-day Notice |
| S038 | 2010-11-15 | 30-day Notice |
| S037 | 2010-11-12 | Normal 180 Day Track No User Fee |
| S036 | 2010-04-21 | 30-day Notice |
| S035 | 2010-03-11 | 30-day Notice |
| S034 | ||
| S033 | ||
| S032 | 2009-09-01 | Special (immediate Track) |
| S031 | 2009-03-31 | Normal 180 Day Track No User Fee |
| S030 | 2009-03-12 | 30-day Notice |
| S029 | 2009-02-11 | Real-time Process |
| S028 | 2008-12-23 | 30-day Notice |
| S027 | 2008-12-09 | Special (immediate Track) |
| S026 | 2008-02-25 | 135 Review Track For 30-day Notice |
| S025 | 2008-02-04 | 30-day Notice |
| S024 | 2008-01-28 | 30-day Notice |
| S023 | 2007-07-10 | 135 Review Track For 30-day Notice |
| S022 | 2007-05-23 | 135 Review Track For 30-day Notice |
| S021 | 2007-02-23 | Normal 180 Day Track |
| S020 | 2006-11-07 | Real-time Process |
| S019 | 2006-09-01 | Normal 180 Day Track No User Fee |
| S018 | 2006-08-29 | Normal 180 Day Track No User Fee |
| S017 | 2006-08-22 | 30-day Notice |
| S016 | 2006-06-21 | 30-day Notice |
| S015 | 2006-01-23 | Special (immediate Track) |
| S014 | ||
| S013 | 2005-11-21 | Normal 180 Day Track |
| S012 | 2005-11-14 | Normal 180 Day Track |
| S011 | 2005-11-16 | Real-time Process |
| S010 | 2005-07-21 | Real-time Process |
| S009 | ||
| S008 | ||
| S007 | 2004-02-02 | 30-day Notice |
| S006 | 2003-07-22 | 30-day Notice |
| S005 | 2003-04-15 | 30-day Notice |
| S004 | 2003-01-24 | 30-day Notice |
| S003 | 2002-12-16 | 30-day Notice |
| S002 | 2002-03-12 | Special (immediate Track) |
| S001 | 2002-01-28 | Normal 180 Day Track |