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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 AND MULTI-FENESTRATED SEPTAL OCCLUDER
Classification Nameoccluder, patent ductus, arteriosus
ApplicantAGA MEDICAL CORP.
PMA NumberP000039
Supplement NumberS045
Date Received04/24/2012
Decision Date05/24/2012
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Modify the statistical sampling plan for receiving inspections of components of the subject devices.
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