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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, 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 NumberS005
Date Received04/15/2003
Decision Date05/13/2003
Product Code
MAE[ Registered Establishments with MAE ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Alternate supplier for the end screw attachment of the device as well as the delivery cable distal end screw, and proximal screw attachment on the delivery cable.
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