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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: this medical device record is a supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameAMPLATZER DUCT OCCLUDER
Classification Nameoccluder, patent ductus, arteriosus
Generic Nametranscatheter patent ductus arterious occlusion device
ApplicantAGA MEDICAL CORP.
PMA NumberP020024
Supplement NumberS024
Date Received03/06/2009
Decision Date12/23/2010
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for updates to the labeling of the amplatzer duct occluder to reflect the findings of the post approval study.
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