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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 SEPTAL OCCLUDER AND AMPLATZER MULTIFENESTRATED SEPTAL OCCLUDER-CRIBRIFORM
Classification Nameoccluder, patent ductus, arteriosus
Generic Nameoccluder, patent ductus, arteriosus
Applicant
St. Jude Medical Cardiovascular Division
5050 nathan lane north
plymouth, MN 55442
PMA NumberP000039
Supplement NumberS023
Date Received07/10/2007
Decision Date12/04/2007
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Type135 review track for 30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for aga medical corporation to become the primary source for the laser welding process, while retaining the current vendor as a secondary source.
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