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 addition of a sterilization chamber (chamber 5) at the steris sterilization facility in costa rica
| Device | Amplatzer Septal Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | Abbott Medical |
| Date Received | 2021-08-24 |
| Decision Date | 2021-09-22 |
| PMA | P000039 |
| Supplement | S075 |
| Product Code | MLV |
| 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 |