PMA P190009S007
- Device
- OPRA™ Implant System
- Applicant
- Integrum AB
- PMA number
- P190009
- Supplement
- S007
- Product code
- PJY
- Decision date
- 2025-01-15
- Classification
- Orthopedic
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Approval order statement
- The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P190009
Current openFDA PMA Record#
- Device
- OPRA™ Implant System
- Applicant
- Integrum AB
- PMA number
- P190009
- Supplement
- S007
- Product code
- PJY
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Decision date
- 2025-01-15
- Decision code
- APPR
- Date received
- 2024-10-18
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P190009