PMA P190009S005
- Device
- OPRA Implant System
- Applicant
- Integrum AB
- PMA number
- P190009
- Supplement
- S005
- Product code
- PJY
- Decision date
- 2024-04-09
- Classification
- Orthopedic
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Approval order statement
- approval for minor design changes to the Axor II component to decrease the risk of incorrect prosthetic donning
Current openFDA PMA Record#
- Device
- OPRA Implant System
- Applicant
- Integrum AB
- PMA number
- P190009
- Supplement
- S005
- Product code
- PJY
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Decision date
- 2024-04-09
- Decision code
- APPR
- Date received
- 2024-01-30
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Approval order statement
- approval for minor design changes to the Axor II component to decrease the risk of incorrect prosthetic donning