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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 Post Infarct Muscular VSD Occluder
Classification Nametranscatheter septal occluder
Generic Nametranscatheter septal occluder
Applicant
Abbott Medical
177 county road b east
st. paul, MN 55117
HDE NumberH070005
Supplement NumberS001
Date Received02/09/2017
Decision Date04/13/2017
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol - osb
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the protocol for the post-approval study (pas) protocol.
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