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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 NumberS016
Date Received04/24/2020
Decision Date05/23/2020
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Type30-day notice
Supplement Reason process change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Add a new sterilization cycle at an approved sterilization facility including the implementation of a new final pack configuration and optimized shippers.
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