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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
Abbott Medical
5050 nathan lane north
plymouth, MN 55442
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.