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U.S. Department of Health and Human Services

Devices@FDA
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceOPRA™ Implant System
Generic NameOsseoanchored prostheses for the rehabilitation of transfemoral amputees
ApplicantIntegrum AB
Krokslatts Fabriker 50
Mölndal SE-431 37
PMA NumberP190009
Supplement NumberS007
Date Received10/18/2024
Decision Date01/15/2025
Product Code PJY 
Advisory Committee Orthopedic
Clinical TrialsNCT01725711
Supplement TypeNormal 180 Day Track No User Fee
Supplement Reason Postapproval Study Protocol
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P190009
Post-Approval StudyShow Report Schedule and Study Progress
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