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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 AND 180 DEGREE DELIVERY SYSTEM
Classification Nameoccluder, patent ductus, arteriosus
Generic Nametranscatheter patent ductus arterious occlusion device
ApplicantAGA MEDICAL CORP.
PMA NumberP020024
Supplement NumberS015
Date Received11/03/2006
Decision Date05/03/2007
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track no user fee
Supplement Reason pas protocal supplement ode/oir
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval of the revised post-approval study.
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