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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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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 HDE to get an up-to-date view of this device.
 
Trade NameAMPLATZER PFO OCCLUDER
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
AGA MEDICAL CORP.
682 mendelssohn ave.
golden valley, MN 55427
HDE NumberH000007
Supplement NumberS005
Date Received02/02/2004
Decision Date09/16/2005
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
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