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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.
 
DeviceAMPLATZER DUCT OCCLUDER
Classification Nameoccluder, patent ductus, arteriosus
Generic Nameoccluder, patent ductus, arteriosus
Applicant
AGA MEDICAL CORP.
5050 nathan lane north
plymouth, MN 55442
PMA NumberP020024
Supplement NumberS035
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 - manufacturer/sterilizer/packager/supplier
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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