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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 NumberS004
Date Received08/29/2003
Decision Date10/31/2003
Product Code
MLV[ Registered Establishments with MLV ]
Docket Number 02M-0167
Advisory Committee Cardiovascular
Supplement Typespecial (immediate track)
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for a change to the labeling to add echocardiographic sizing criteria.
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