PMA supplement
P000057 S005: ASCENSION MCP
FDA PMA supplement · Normal 180 Day Track No User Fee · Smith & Nephew, Inc.
Key facts
| Original PMA | P000057 |
|---|---|
| Supplement number | S005 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Postapproval Study Protocol - OSB |
| Trade name | ASCENSION MCP |
| Generic name | Finger semi-constrained pyrolytic carbon uncemented prosthesis |
| Applicant | Smith & Nephew, Inc. |
| Product code | NEG |
| Received date | Oct 5, 2009 |
| Decision date | Dec 4, 2009 |
At a glance
- No Expedited review granted
- No Approval order on file
- No Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: