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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.
plymouth, MN 55427
HDE NumberH000007
Supplement NumberS008
Date Received07/13/2005
Decision Date11/10/2005
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for changes to the labeling to support compatibility of the devices with mr environments up to 3. 0 tesla.
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