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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 45 DEGREE DELIVERY AND EXCHANGE SYSTEMS
Classification Nameoccluder, patent ductus, arteriosus
Generic Nameamplatzer 45(deg) delivery & exchange systems
ApplicantAGA MEDICAL CORP.
PMA NumberP000039
Supplement NumberS003
Date Received12/16/2002
Decision Date01/15/2003
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 in the manufacturing process to obtain an alternate supplier for components used with the amplatzer septal occluder and delivery exchange systems.
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