PMA supplement
P120016 S021: VASCADE VASCULAR CLOSURE SYSTEM (VCS)
FDA PMA supplement · Normal 180 Day Track · Cardiva Medical, Inc.
Key facts
| Original PMA | P120016 |
|---|---|
| Supplement number | S021 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | VASCADE VASCULAR CLOSURE SYSTEM (VCS) |
| Generic name | Device, hemostasis, vascular |
| Applicant | Cardiva Medical, Inc. |
| Product code | MGB |
| Received date | Nov 4, 2016 |
| Decision date | Mar 30, 2018 |
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: