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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 NumberS012
Date Received11/25/2019
Decision Date01/24/2020
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Clinical Trials NCT03165526
Supplement Typenormal 75 day track
Supplement Reason postapproval study protocol
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval of the revised protocol for the post-approval study (pas) protocol.
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