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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 NameOPRA Implant System
Classification Nameosseoanchored prostheses for the rehabilitation of transfemoral amputees
Generic Nameosseoanchored prostheses for the rehabilitation of transfemoral amputees
Applicant
Integrum AB
lilla bommen 1
goteborg SE-41-411
HDE NumberH080004
Supplement NumberS005
Date Received04/19/2017
Decision Date06/26/2017
Product Code
PJY[ Registered Establishments with PJY ]
Advisory Committee Orthopedic
Clinical Trials NCT01725711
Supplement Typenormal 75 day track
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval for patient labeling to provide additional instructions on the use of the device.
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