PMA supplement
P850049 S008: GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER
FDA PMA supplement · Normal 180 Day Track · Cook, Inc.
Key facts
| Original PMA | P850049 |
|---|---|
| Supplement number | S008 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | GIANTURCO-ROEHM BIRD'S NEST(TM) VENA CAVA FILTER |
| Generic name | FILTER, INTRAVASCULAR, CARDIOVASCULAR |
| Applicant | Cook, Inc. |
| Product code | DTK |
| Received date | Jun 13, 2000 |
| Decision date | Feb 13, 2002 |
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: