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 for converting the nitinol wire used in the manufacture of these devices from a black oxide surface finish to a chemically etched surface finish.
| Device | AMPLATZER VSD MUSCULAR OCCLUDER |
| Classification Name | Transcatheter Septal Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | Abbott Medical |
| Date Received | 2013-02-06 |
| Decision Date | 2014-10-29 |
| PMA | P040040 |
| Supplement | S022 |
| Product Code | MLV |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 5050 Nathan Lane North plymouth, MN 55442 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P040040 | Original Filing | |
| S045 | 2021-11-22 | Real-time Process |
| S044 | 2021-06-28 | 30-day Notice |
| S043 | 2020-05-06 | 30-day Notice |
| S042 | 2020-04-24 | 30-day Notice |
| S041 | ||
| S040 | 2020-03-19 | 30-day Notice |
| S039 | 2020-03-17 | 30-day Notice |
| S038 | 2019-09-26 | 30-day Notice |
| S037 | 2019-06-24 | Normal 180 Day Track No User Fee |
| S036 | 2019-02-27 | 30-day Notice |
| S035 | 2019-02-15 | Normal 180 Day Track No User Fee |
| S034 | 2019-01-03 | 30-day Notice |
| S033 | 2018-02-12 | 30-day Notice |
| S032 | ||
| S031 | 2017-07-06 | 30-day Notice |
| S030 | 2017-01-26 | 30-day Notice |
| S029 | 2016-07-01 | 30-day Notice |
| S028 | 2016-04-06 | 30-day Notice |
| S027 | 2016-03-14 | 30-day Notice |
| S026 | 2016-01-19 | Normal 180 Day Track No User Fee |
| S025 | 2015-10-30 | Normal 180 Day Track No User Fee |
| S024 | 2015-08-21 | Normal 180 Day Track No User Fee |
| S023 | 2013-02-19 | 135 Review Track For 30-day Notice |
| S022 | 2013-02-06 | Normal 180 Day Track |
| S021 | 2012-05-14 | 30-day Notice |
| S020 | 2012-04-24 | 30-day Notice |
| S019 | 2011-09-20 | 30-day Notice |
| S018 | 2011-03-09 | 30-day Notice |
| S017 | ||
| S016 | 2011-01-19 | 30-day Notice |
| S015 | 2010-11-15 | 30-day Notice |
| S014 | 2010-06-09 | Normal 180 Day Track No User Fee |
| S013 | 2010-04-21 | 30-day Notice |
| S012 | 2010-03-11 | 30-day Notice |
| S011 | ||
| S010 | ||
| S009 | 2009-02-11 | Real-time Process |
| S008 | 2008-12-23 | 30-day Notice |
| S007 | 2008-12-09 | Special (immediate Track) |
| S006 | 2008-11-28 | Normal 180 Day Track No User Fee |
| S005 | 2008-02-25 | 135 Review Track For 30-day Notice |
| S004 | 2008-02-04 | 30-day Notice |
| S003 | 2008-01-28 | 30-day Notice |
| S002 | 2007-12-14 | 30-day Notice |
| S001 | 2007-11-06 | 30-day Notice |