PMA
P900007: COOK CHORIONIC VILLUS SAMPLING SET
FDA PMA · Catheter, sampling, chorionic villus · Cook Incorporated
Key facts
| PMA number | P900007 |
|---|---|
| Trade name | COOK CHORIONIC VILLUS SAMPLING SET |
| Generic name | Catheter, sampling, chorionic villus |
| Applicant | Cook Incorporated |
| Owner/operator | COOK, INC. |
| Product code | LLX |
| Approval date | Sep 30, 1994 |
| Docket number | 94M-0364 |
| Notice date | Nov 14, 1994 |
| Establishment registration | 1820334 |
| FEI number | 1820334 |
At a glance
- 1–9 Supplements
- Apr 2, 2009 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: