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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 (ADO)
Classification Nameoccluder, patent ductus, arteriosus
Generic Nametranscatheter patent ductus arterious occlusion device
ApplicantAGA MEDICAL CORP.
PMA NumberP020024
Supplement NumberS038
Date Received02/06/2013
Decision Date10/29/2014
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for converting the nitinol wire used in the manufacture of these devices from a black oxide surface finish to a chemically etched surface finish.
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