AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM

Occluder, Patent Ductus, Arteriosus

FDA Premarket Approval P020024

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.

Pre-market Approval Supplement Details

Approval for the amplatzer duct occluder and 180 degree delivery system. The percutaneous, transcatheter occlusion device is indicated for the non-surgical closure of patent ductus arteriosus (pda).

• Device: AMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
• Classification Name: Occluder, Patent Ductus, Arteriosus
• Generic Name: Occluder, Patent Ductus, Arteriosus
• Applicant: Abbott Medical
• Date Received: 2002-06-24
• Decision Date: 2003-05-14
• Notice Date: 2006-02-16
• PMA: P020024
• Supplement: S
• Product Code: MAE
• Docket Number: 06M-0075
• 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 Labeling Part 2
• Post-Approval Study: Show Report Schedule and Study Progress
• Approval Order: Approval Order

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

NIH GUDID Devices

Device ID	PMA	Supp
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