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.
Labeling changes to update the mri conditional information in the instructions for use (ifu) and patient implant cards (pic) supplied with the impacted amplatzer occluder devices
| Device | Amplatzer Septal Occluder and Amplatzer Cribriform Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | Abbott Medical |
| Date Received | 2021-11-22 |
| Decision Date | 2022-01-13 |
| PMA | P000039 |
| Supplement | S076 |
| Product Code | MLV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| 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 |