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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 rd. b e.
st. paul, MN 55117
HDE NumberH070005
Supplement NumberS021
Date Received05/06/2022
Decision Date07/20/2022
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 
Modifications to the instructions for use to include a new section with the findings of the post-approval study.
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