HDE supplement
H010005 S007: ASCENSION PIP
FDA HDE supplement · normal 75 day track · Smith & Nephew, Inc.
Key facts
| Original HDE | H010005 |
|---|---|
| Supplement number | S007 |
| Supplement type | normal 75 day track |
| Reason for the supplement | change design/components/specifications/material |
| Trade name | ASCENSION PIP |
| Generic name | Finger semi-constrained pyrolytic carbon uncemented prosthesis |
| Applicant | Smith & Nephew, Inc. |
| Product code | NEG |
| Received date | Sep 10, 2013 |
| Decision date | Mar 6, 2014 |
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: