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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 DUCT OCCLUDER, AMPLATZER 180 DELIVERY AND EXCHANGE SYSTEMS (PTFE)
Classification Nameoccluder, patent ductus, arteriosus
Generic Nametranscatheter patent ductus arterious occlusion device
ApplicantAGA MEDICAL CORP.
PMA NumberP020024
Supplement NumberS034
Date Received09/22/2011
Decision Date10/21/2011
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 
Change the current seal test method from manual to semiautomatic.
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