PMA supplement
P890024 S005: TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER
FDA PMA supplement · Normal 180 Day Track · Smiths Industries Medical Systems, Inc.
Key facts
| Original PMA | P890024 |
|---|---|
| Supplement number | S005 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | TROPHOCAN TM CHORIONIC VILLUS SAMPLING CATHETER |
| Generic name | Catheter, sampling, chorionic villus |
| Applicant | Smiths Industries Medical Systems, Inc. |
| Product code | LLX |
| Received date | May 4, 1992 |
| Decision date | Dec 27, 1993 |
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: