Approval for the second generation amplatzer duct occluder ii (ado ii) device. The device, as modified, will be marketed under the trade name amplatzer duct occluder ii and is indicated for the non-surgical closure of patent ductus arteriosius (pda).
| Device | AMPLATZER DUCT OCCLUDER II |
| Classification Name | Occluder, Patent Ductus, Arteriosus |
| Generic Name | Occluder, Patent Ductus, Arteriosus |
| Applicant | Abbott Medical |
| Date Received | 2013-01-22 |
| Decision Date | 2013-08-18 |
| PMA | P020024 |
| Supplement | S037 |
| Product Code | MAE |
| 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 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P020024 | | Original Filing |
| S066 |
2021-11-22 |
Real-time Process |
| S065 |
2021-06-28 |
30-day Notice |
| S064 |
2020-05-06 |
30-day Notice |
| S063 |
2020-04-24 |
30-day Notice |
| S062 | | |
| S061 | | |
| S060 |
2020-03-19 |
30-day Notice |
| S059 |
2020-03-17 |
30-day Notice |
| S058 |
2019-09-26 |
30-day Notice |
| S057 |
2019-06-24 |
Normal 180 Day Track No User Fee |
| S056 |
2019-02-27 |
30-day Notice |
| S055 |
2019-02-15 |
Normal 180 Day Track No User Fee |
| S054 | | |
| S053 |
2019-01-03 |
30-day Notice |
| S052 |
2018-08-13 |
Normal 180 Day Track |
| S051 |
2018-02-12 |
30-day Notice |
| S050 | | |
| S049 |
2017-07-06 |
30-day Notice |
| S048 |
2017-06-19 |
Normal 180 Day Track No User Fee |
| S047 |
2017-01-26 |
30-day Notice |
| S046 |
2016-07-01 |
30-day Notice |
| S045 |
2016-04-06 |
30-day Notice |
| S044 |
2016-03-14 |
30-day Notice |
| S043 |
2016-03-14 |
30-day Notice |
| S042 |
2015-10-30 |
Normal 180 Day Track No User Fee |
| S041 |
2015-08-21 |
Normal 180 Day Track No User Fee |
| S040 |
2013-09-11 |
Normal 180 Day Track No User Fee |
| S039 |
2013-02-19 |
135 Review Track For 30-day Notice |
| S038 |
2013-02-06 |
Normal 180 Day Track |
| S037 |
2013-01-22 |
Normal 180 Day Track |
| S036 |
2012-05-14 |
30-day Notice |
| S035 |
2012-04-24 |
30-day Notice |
| S034 |
2011-09-20 |
30-day Notice |
| S033 |
2011-03-09 |
30-day Notice |
| S032 | | |
| S031 |
2011-01-19 |
30-day Notice |
| S030 |
2010-11-15 |
30-day Notice |
| S029 |
2010-04-21 |
30-day Notice |
| S028 |
2010-03-11 |
30-day Notice |
| S027 | | |
| S026 | | |
| S025 |
2009-03-12 |
30-day Notice |
| S024 |
2009-03-06 |
Normal 180 Day Track No User Fee |
| S023 |
2009-02-11 |
Real-time Process |
| S022 |
2008-12-23 |
30-day Notice |
| S021 | | |
| S020 |
2008-02-25 |
135 Review Track For 30-day Notice |
| S019 |
2008-02-04 |
30-day Notice |
| S018 |
2008-01-28 |
30-day Notice |
| S017 |
2007-07-10 |
135 Review Track For 30-day Notice |
| S016 |
2007-05-23 |
135 Review Track For 30-day Notice |
| S015 |
2006-11-03 |
Normal 180 Day Track No User Fee |
| S014 |
2006-11-07 |
Real-time Process |
| S013 |
2006-08-29 |
Normal 180 Day Track No User Fee |
| S012 |
2006-08-22 |
30-day Notice |
| S011 |
2006-06-21 |
30-day Notice |
| S010 |
2005-11-14 |
Normal 180 Day Track |
| S009 |
2005-11-03 |
30-day Notice |
| S008 |
2005-11-02 |
Real-time Process |
| S007 |
2005-11-16 |
Real-time Process |
| S006 |
2005-10-13 |
Real-time Process |
| S005 |
2005-07-21 |
Real-time Process |
| S004 | | |
| S003 | | |
| S002 |
2004-02-02 |
30-day Notice |
| S001 |
2003-10-14 |
30-day Notice |
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