PMA
N17433: PRE OP SPONGE
FDA PMA · Davis & Geck, Inc.
Key facts
| PMA number | N17433 |
|---|---|
| Trade name | PRE OP SPONGE |
| Applicant | Davis & Geck, Inc. |
| Approval date | Oct 12, 1978 |
| FEI number | 2650016 |
At a glance
- None Supplements
- Oct 12, 1978 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- None 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: