PMA
P850049: COOK BIRD'S NEST VENA CAVA FILTER
FDA PMA · FILTER, INTRAVASCULAR, CARDIOVASCULAR · Cook, Inc.
Key facts
| PMA number | P850049 |
|---|---|
| Trade name | COOK BIRD'S NEST VENA CAVA FILTER |
| Generic name | FILTER, INTRAVASCULAR, CARDIOVASCULAR |
| Applicant | Cook, Inc. |
| Owner/operator | COOK, INC. |
| Product code | DTK |
| Approval date | Apr 26, 1989 |
| Docket number | 89M-0193 |
| Notice date | Jun 29, 1989 |
| Establishment registration | 1820334 |
| FEI number | 1820334 |
At a glance
- 10–99 Supplements
- Feb 3, 2006 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- No Withdrawn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: