PMA
P190009: OPRA Implant System
FDA PMA · Osseoanchored prostheses for the rehabilitation of transfemoral amputees · Integrum AB
Key facts
| PMA number | P190009 |
|---|---|
| Trade name | OPRA Implant System |
| Generic name | Osseoanchored prostheses for the rehabilitation of transfemoral amputees |
| Applicant | Integrum AB |
| Owner/operator | Integrum AB |
| Product code | PJY |
| Approval date | Dec 18, 2020 |
| Docket number | 20M-2324 |
| Notice date | Jan 28, 2021 |
| Establishment registration | 3011386779 |
| FEI number | 3011386779 |
At a glance
- 10–99 Supplements
- Apr 15, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 100–999 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: