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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™ P.I. 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 NumberS023
Date Received07/22/2024
Decision Date10/01/2024
Product Code
MLV[ Registered Establishments with MLV ]
Advisory Committee Cardiovascular
Supplement Typenormal 75 day track
Supplement Reason location change - manufacturer/sterilizer/packager/supplier
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for the addition of centerpiece tijuana mexico as an alternative ethylene oxide (eo) sterilization facility for the sterilization of the provided devices in scope approved under the pma/hde numbers p000039, p02004, p200049, p120021, p040040, h070005, p190023.
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