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U.S. Department of Health and Human Services

Humanitarian Device Exemption (HDE)
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Trade NameSonalleve MR-HIFU
Generic Nameablation system, high intensity focused ultrasound (hifu), mr guided, orthopedic
Applicant
Profound Medical Inc.
2400 skymark avenue, unit 6
mississauga, ontario canada L4W 5
HDE NumberH190003
Date Received04/10/2019
Decision Date11/27/2020
Product Code
QND[ Registered Establishments with QND ]
Docket Number 20M-2238
Notice Date 11/27/2020
Advisory Committee Orthopedic
Clinical Trials NCT02349971
Supplement Typehde original
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
The sonalleve mr-hifu is intended to be used for the treatment of osteoid osteomas in the extremities.
Approval Order Approval Order
Summary Summary of Safety and Probable Benefit
Labeling Labeling
Labeling Part 2
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