OPRA System
FDA premarket approval P190009/S002 · decided 2021-02-12
Approval details
- PMA number
- P190009
- Supplement
- S002
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- OPRA System
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Applicant
- Integrum AB
- Date received
- 2021-01-15
- Decision date
- 2021-02-12
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- PJY
- Advisory committee
- Orthopedic
- Expedited review
- No
- Location
- Mölndal
- Statement
- Approval of the protocol for the post-approval study (PAS) protocol
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