|
Trade Name | OPRA Implant System |
Classification Name | osseoanchored prostheses for the rehabilitation of transfemoral amputees |
Generic Name | osseoanchored prostheses for the rehabilitation of transfemoral amputees |
Applicant |
INTEGRUM AB |
lilla bommen 1 |
goteborg SE-41-411 |
|
HDE Number | H080004 |
Supplement Number | S005 |
Date Received | 04/19/2017 |
Decision Date | 06/26/2017 |
Product Code | |
Advisory Committee |
Orthopedic |
Clinical Trials |
NCT01725711
|
Supplement Type | normal 75 day track |
Supplement Reason | labeling change - indications/instructions/shelf life/tradename |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for patient labeling to provide additional instructions on the use of the device. |