Approval for an alternate source of routine bioburden and sterility testing, as well as changes to the bioburden testing protocol.
| Device | AMPLATZER DUCT OCCLUDER |
| Classification Name | Occluder, Patent Ductus, Arteriosus |
| Generic Name | Occluder, Patent Ductus, Arteriosus |
| Applicant | Abbott Medical |
| Date Received | 2013-02-19 |
| Decision Date | 2013-07-26 |
| PMA | P020024 |
| Supplement | S039 |
| Product Code | MAE |
| Advisory Committee | Cardiovascular |
| Supplement Type | 135 Review Track For 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 5050 Nathan Lane North plymouth, MN 55442 |
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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