|
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 | S004 |
Date Received | 02/13/2017 |
Decision Date | 04/28/2017 |
Product Code | |
Advisory Committee |
Orthopedic |
Supplement Type | normal 75 day track |
Supplement Reason | location change - manufacturer/sterilizer/packager/supplier |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement Approval for a manufacturing site located at mastec components ab located at industrivagen 7, ulricehamn vastra gotalands lan [se-14], sweden 52390 for the manufacture of the axor ii component. |