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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 PFO OCCLUDER AMPLATZER 45 DEGREE DELIVERY AND EXANGE SYSTEMS
Classification Nameoccluder, patent ductus, arteriosus
ApplicantAGA MEDICAL CORP.
PMA NumberP000039
Supplement NumberS006
Date Received07/22/2003
Decision Date08/21/2003
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 
Alternate supplier for the delivery sheath, dilator, and loading device components of the amplatzer septal occluder and amplatzer 45 degree delivery and exchange systems and some minor manufacturing changes to allow for color coding of components.
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