PMA supplement
P900007 S001: COOK CHORIONIC VILLUS SAMPLING SET
FDA PMA supplement · Normal 180 Day Track · Cook Incorporated
Key facts
| Original PMA | P900007 |
|---|---|
| Supplement number | S001 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Other |
| Trade name | COOK CHORIONIC VILLUS SAMPLING SET |
| Generic name | Catheter, sampling, chorionic villus |
| Applicant | Cook Incorporated |
| Product code | LLX |
| Received date | Jan 15, 1998 |
| Decision date | Jul 8, 1998 |
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: