HDE supplement
H080004 S005: OPRA Implant System
FDA HDE supplement · normal 75 day track · INTEGRUM AB
Key facts
| Original HDE | H080004 |
|---|---|
| Supplement number | S005 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | OPRA Implant System |
| Generic name | Osseoanchored prostheses for the rehabilitation of transfemoral amputees |
| Applicant | INTEGRUM AB |
| Product code | PJY |
| Received date | Apr 19, 2017 |
| Decision date | Jun 26, 2017 |
At a glance
- No Approval order on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About HDE supplements
An HDE supplement asks FDA to approve a change to a Humanitarian Use Device that already holds a humanitarian device exemption.
Source: U.S. Food and Drug Administration (FDA), Humanitarian Device Exemption (HDE) database · Source date: