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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 SEPTAL OCCLUDER
Classification Nameoccluder, patent ductus, arteriosus
ApplicantAGA MEDICAL CORP.
PMA NumberP000039
Supplement NumberS020
Date Received11/07/2006
Decision Date01/30/2007
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: packaging
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modifications to the device packaging and inclusion of a three year shelf life for the original amplatzer duct occluder and septal occluder delivery and exchange systems.
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