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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 AMPLATZER MULTI-FENESTRATED SEPTAL OCCLUDER-CRIBRIFORM
Classification Nameoccluder, patent ductus, arteriosus
ApplicantAGA MEDICAL CORP.
PMA NumberP000039
Supplement NumberS049
Date Received02/19/2013
Decision Date07/26/2013
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an alternate source of routine bioburden and sterility testing, as well as changes to the bioburden testing protocol.
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