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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 (ASO) DEVICE, AMPLATZER DUCT OCCLUDER AND AMPLATZER DELIVERY AND EXCHANGE SYSTEM
Classification Nameoccluder, patent ductus, arteriosus
ApplicantAGA MEDICAL CORP.
PMA NumberP000039
Supplement NumberS011
Date Received11/30/2005
Decision Date05/12/2006
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the use of an alternate pigment to be used during manufacture of the ptfe tubing components of the amplatzer delivery and exchange system sheaths, dilators and loaders.
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