Amplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder

FDA Premarket Approval P020024 S064

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.

Pre-market Approval Supplement Details

Implementation of parametric release as part of the sterilization process at the midwestern sterilization corporation facility

DeviceAmplatzer Duct Occluder, Amplatzer Duct Occluder II, Amplatzer Piccolo Occluder
Generic NameOccluder, Patent Ductus, Arteriosus
ApplicantAbbott Medical
Date Received2020-05-06
Decision Date2020-06-04
PMAP020024
SupplementS064
Product CodeMAE 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product No
Applicant Address Abbott Medical 5050 Nathan Lane North plymouth, MN 55442

Supplemental Filings

Supplement NumberDateSupplement Type
P020024Original Filing
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

NIH GUDID Devices

Device IDPMASupp
05415067031051 P020024 052
05415067031044 P020024 052
05415067031037 P020024 052
05415067031020 P020024 052
05415067031013 P020024 052
05415067031006 P020024 052
05415067030993 P020024 052
05415067030986 P020024 052
05415067030979 P020024 052

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