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 septal occluder (aso) and the amplatzer exchange system. The amplatzer septal occluder (aso) device is indicated for the occlusion of atrial septal defects (asd) in secundum position. The aso device is also indicated in patients who have undergone a fenestrated fontan procedure and who now require closure of the fenestration. Patients indicated for asd closure have echocardiographic evidence of ostium secundum atrial septal defect and clinical evidence of right ventricular volume overload (i. E. , 1. 5:1 degree of left to right shunt or rv enlargement). The amplatzer exchange system is intended for the removal of an amplatzer delivery sheath and subsequent exchange for an amplatzer delivery sheath of equal or larger diameter.
| Device | THE AMPLATZER(R) SEPTAL OCCLUDER (ASO) AND THE AMPLATZER EXCHANGE SYSTEM |
| Classification Name | Transcatheter Septal Occluder |
| Generic Name | Transcatheter Septal Occluder |
| Applicant | Abbott Medical |
| Date Received | 2000-09-01 |
| Decision Date | 2001-12-05 |
| Notice Date | 2002-06-27 |
| PMA | P000039 |
| Supplement | S |
| Product Code | MLV |
| Docket Number | 02M-0271 |
| 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 |
|---|---|---|
| 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 |