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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, Abutment component
Generic NameOsseoanchored prostheses for the rehabilitation of transfemoral amputees
ApplicantIntegrum AB
Krokslatts Fabriker 50
Mölndal SE-431 37
PMA NumberP190009
Supplement NumberS006
Date Received09/27/2024
Decision Date11/20/2025
Product Code PJY 
Advisory Committee Orthopedic
Clinical TrialsNCT01725711
Supplement Type135 Review Track For 30-Day Notice
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
approval of an addition of a Low Plasticity Burnishing (LPB) step in the manufacturing process of the Abutment component of the OPRA device.
Post-Approval StudyShow Report Schedule and Study Progress
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