PMA
P000057: ASCENSION MCP
FDA PMA · Finger semi-constrained pyrolytic carbon uncemented prosthesis · Smith & Nephew, Inc.
Key facts
| PMA number | P000057 |
|---|---|
| Trade name | ASCENSION MCP |
| Generic name | Finger semi-constrained pyrolytic carbon uncemented prosthesis |
| Applicant | Smith & Nephew, Inc. |
| Owner/operator | Smith & Nephew, Inc. |
| Product code | NEG |
| Approval date | Nov 19, 2001 |
| Docket number | 01M-0530 |
| Notice date | Nov 29, 2001 |
| Establishment registration | 1020279 |
| FEI number | 1020279 |
At a glance
- 10–99 Supplements
- Dec 31, 2025 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: