PMA supplement
P900007 S005: COOK CHORIONIC VILLUS SAMPLING SET
FDA PMA supplement · Real-Time Process · Cook Incorporated
Key facts
| Original PMA | P900007 |
|---|---|
| Supplement number | S005 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | COOK CHORIONIC VILLUS SAMPLING SET |
| Generic name | Catheter, sampling, chorionic villus |
| Applicant | Cook Incorporated |
| Product code | LLX |
| Received date | Nov 17, 2008 |
| Decision date | Apr 2, 2009 |
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: