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 changes to the labeling to support compatibility of the devices with mr environments up to 3. 0 tesla. The device, as modified, will be marketed under the trade name amplatzer septal occluder (aso) device with the following indications for use: 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).
| Device | AMPLATZER SEPTAL OCCLUDER (ASO) DEVICE |
| Classification Name | Occluder, Patent Ductus, Arteriosus |
| Generic Name | Occluder, Patent Ductus, Arteriosus |
| Applicant | Abbott Medical |
| Date Received | 2005-07-21 |
| Decision Date | 2005-10-13 |
| PMA | P000039 |
| Supplement | S010 |
| Product Code | MAE |
| 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 |