This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the amplatzer muscular vsd occluder. The device is indicated for use in patients with a complex ventricular septal defect (vsd) of significant size to warrant closure (large volume left to right shunt, pulmonary hypertension and/or clinical symptoms of congestive heart failure) who are considered to be at high risk for standard transatrial or transarterial surgical closure based on anatomical conditions and/or based on overall medical condition. High risk anatomical factors for transatrial or transarterial surgical closure include patients: 1) requiring left ventriculotomy or an extensive right ventriculotomy; 2) with a failed previous vsd closure; 3) with multiple apical and/or anterior muscular vsds (? Swiss cheese septum? ); or 4) with posterior apical vsds covered by trabeculae.
| Device | AMPLATZER MUSCULAR VSD OCCLUDER |
| Classification Name | Transcatheter Septal Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | Abbott Medical |
| Date Received | 2004-09-30 |
| Decision Date | 2007-09-07 |
| Notice Date | 2007-11-19 |
| PMA | P040040 |
| Supplement | S |
| Product Code | MLV |
| Docket Number | 07M-0446 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 5050 Nathan Lane North plymouth, MN 55442 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |