OPRA Implant System
FDA premarket approval P190009/S009 · decided 2025-08-14
Approval details
- PMA number
- P190009
- Supplement
- S009
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- OPRA Implant System
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Applicant
- Integrum AB
- Date received
- 2025-07-24
- Decision date
- 2025-08-14
- Days to decision
- 21 days
- Decision code
- APPR
- Product code
- PJY
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mölndal
- Statement
- Approval of the revised protocol for the post-approval study (PAS) referenced above. The PAS protocol has been submitted to comply with the conditions of approval outlined in our approval order for P190009
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