OPRA Implant System
FDA premarket approval P190009/S005 · decided 2024-04-09
Approval details
- PMA number
- P190009
- Supplement
- S005
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- OPRA Implant System
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Applicant
- Integrum AB
- Date received
- 2024-01-30
- Decision date
- 2024-04-09
- Days to decision
- 70 days
- Decision code
- APPR
- Product code
- PJY
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mölndal
- Statement
- approval for minor design changes to the Axor II component to decrease the risk of incorrect prosthetic donning
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