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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/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.
 
DeviceAMPLATZER DUCT OCCLUDER AND 180 DEGREE DELIVERY SYSTEM
Generic Nameoccluder, patent ductus, arteriosus
ApplicantAbbott Medical
177 county road b east
st. paul, MN 55117
PMA NumberP020024
Date Received06/24/2002
Decision Date05/14/2003
Product Code MAE 
Docket Number 06M-0075
Notice Date 02/16/2006
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH 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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
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 S038 S039 S040 S041 
S042 S043 S044 S045 S046 S047 S048 S049 S051 S052 S053 S055 
S056 S057 S058 S059 S060 S061 S062 S063 S064 S065 S066 
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