HDE supplement
H010005 S010: Ascension PIP
FDA HDE supplement · normal 75 day track · Smith & Nephew, Inc.
Key facts
| Original HDE | H010005 |
|---|---|
| Supplement number | S010 |
| Supplement type | normal 75 day track |
| Reason for the supplement | labeling change - indications/instructions/shelf life/tradename |
| Trade name | Ascension PIP |
| Generic name | High demand, revision, semi-constrained, pyrolytic carbon, uncemented finger prosthesis |
| Applicant | Smith & Nephew, Inc. |
| Product code | OMX |
| Received date | Jan 5, 2024 |
| Decision date | Mar 20, 2024 |
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: