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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameAMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
Classification Nameoccluder, patent ductus, arteriosus
Generic Nametranscatheter patent ductus arterious occlusion device
ApplicantAGA MEDICAL CORP.
PMA NumberP020024
Date Received06/24/2002
Decision Date05/14/2003
Product Code
MAE[ Registered Establishments with MAE ]
Docket Number 06M-0075
Notice Date 02/16/2006
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH Recalls
Approval Order Statement 
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).
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S005 S006 S007 S008 S009 S010 S011 
S012 S013 S014 S015 S016 S017 S018 S019 S020 
S022 S023 S024 S025 S028 S029 S030 S031 S033 
S034 S035 S036 S037 S039 S040 
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