PMA P190009S001
- Device
- OPRA Implant System
- Applicant
- Integrum AB
- PMA number
- P190009
- Supplement
- S001
- Product code
- PJY
- Decision date
- 2021-02-12
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.
Current openFDA PMA Record#
- Device
- OPRA Implant System
- Applicant
- Integrum AB
- PMA number
- P190009
- Supplement
- S001
- Product code
- PJY
- Generic name
- Osseoanchored prostheses for the rehabilitation of transfemoral amputees
- Decision date
- 2021-02-12
- Decision code
- APPR
- Date received
- 2021-01-15
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Approval order statement
- Approval of the protocol for the post-approval study (PAS) protocol.