HDE supplement
H980002 S006: SR PIP System
FDA HDE supplement · normal 75 day track · Encore Medical L/P. d/b/a DJO Surgical
Key facts
| Original HDE | H980002 |
|---|---|
| Supplement number | S006 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | SR PIP System |
| Generic name | Semi-constrained metal/polymer finger joint prosthesis |
| Applicant | Encore Medical L/P. d/b/a DJO Surgical |
| Product code | MPK |
| Received date | Apr 1, 2016 |
| Decision date | Jun 14, 2016 |
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: