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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
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 NumberS003
Date Received07/15/2016
Decision Date09/15/2016
Product Code
PJY[ Registered Establishments with PJY ]
Advisory Committee Orthopedic
Clinical Trials NCT01725711
Supplement Typenormal 75 day track
Supplement Reason request for adn
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement 
Approval in accordance with 613(b) of the food and drug administration safety and innovation act (fdasia), a determination that the humanitarian use device (hud) meets the conditions of either subclause (i) or (ii) under section 520(m)(6)(a)(i) of the federal food, drug, and cosmetic act (fd&c act), as amended by the fdasia, so that the device may be sold for an amount that exceeds the costs of research and development, fabrication, and distribution of the device (i. E. , for profit). The adn for this device has been determined to be 1. 05 x 4000 = 4,200.
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