This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval of the 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.
| Device | 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 |
| PMA | P190009 |
| Supplement | S002 |
| Product Code | PJY |
| Advisory Committee | Orthopedic |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Integrum AB krokslatts Fabriker 50 molndal Se-43-431 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P190009 | Original Filing | |
| S002 | 2021-01-15 | Normal 180 Day Track No User Fee |
| S001 | 2021-01-15 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 07340152102065 | P190009 | 000 |
| 07340152102201 | P190009 | 000 |
| 07340152102195 | P190009 | 000 |
| 07340152102188 | P190009 | 000 |
| 07340152102171 | P190009 | 000 |
| 07340152102164 | P190009 | 000 |
| 07340152102157 | P190009 | 000 |
| 07340152102140 | P190009 | 000 |
| 07340152102133 | P190009 | 000 |
| 07340152102126 | P190009 | 000 |
| 07340152102119 | P190009 | 000 |
| 07340152102218 | P190009 | 003 |
| 07340152101679 | P190009 | 003 |
| 07340152101686 | P190009 | 003 |
| 07340152101693 | P190009 | 003 |
| 07340152101709 | P190009 | 003 |
| 07340152101716 | P190009 | 003 |
| 07340152102034 | P190009 | 003 |
| 07340152101976 | P190009 | 003 |
| 07340152102225 | P190009 | 003 |
| 07340152101723 | P190009 | 003 |
| 07340152101662 | P190009 | 003 |
| 07340152102027 | P190009 | 003 |
| 07340152101792 | P190009 | 003 |
| 07340152101785 | P190009 | 003 |
| 07340152101778 | P190009 | 003 |
| 07340152101761 | P190009 | 003 |
| 07340152101754 | P190009 | 003 |
| 07340152101747 | P190009 | 003 |
| 07340152101730 | P190009 | 003 |
| 07340152101952 | P190009 | 003 |