HDE supplement
H030009 S008: VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR)
FDA HDE supplement · normal 75 day track · SYNTHES SPINE
Key facts
| Original HDE | H030009 |
|---|---|
| Supplement number | S008 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | VERTICAL EXPANDABLE PROSTHETIC TITANIUM RIB (VEPTR) |
| Generic name | Prosthesis, rib replacement |
| Applicant | SYNTHES SPINE |
| Product code | MDI |
| Received date | Aug 25, 2011 |
| Decision date | Feb 24, 2012 |
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: