OPRA Implant System
FDA premarket approval P190009 · decided 2020-12-18
Approval details
- PMA number
- P190009
- Trade name
- OPRA Implant System
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Applicant
- Integrum AB
- Date received
- 2019-04-05
- Decision date
- 2020-12-18
- Days to decision
- 623 days
- Decision code
- APPR
- Product code
- PJY
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mölndal
- Statement
- Approval for the OPRA Implant System. The device is indicated for patients who have transfemoral amputation due to trauma or cancer and who have or are anticipated to have rehabilitation problems with, or cannot use, a conventional socket prosthesis. The OPRA Implant System is intended for skeletally mature patients.The patient failed to receive benefit from socket prostheses or is expected to not tolerate socket use due to problems such as:1) Recurrent skin infections and ulcerations in the soc
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