PMA
P890024: TROPHOCAN TM
FDA PMA · Catheter, sampling, chorionic villus · Smiths Industries Medical Systems, Inc.
Key facts
| PMA number | P890024 |
|---|---|
| Trade name | TROPHOCAN TM |
| Generic name | Catheter, sampling, chorionic villus |
| Applicant | Smiths Industries Medical Systems, Inc. |
| Product code | LLX |
| Approval date | Aug 9, 1990 |
| Docket number | 90M-0316 |
| Notice date | Oct 23, 1990 |
At a glance
- 1–9 Supplements
- Dec 27, 1993 Latest supplement decision
- Yes Withdrawn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: