PMA supplement
P990037 S019: DIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT
FDA PMA supplement · Real-Time Process · Vascular Solutions, Inc.
Key facts
| Original PMA | P990037 |
|---|---|
| Supplement number | S019 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | DIAGNOSTIC DUETT AND DUETT PRO SEALING DEVICES AND D-STAT FLOWABLE HEMOSTAT |
| Generic name | Device, hemostasis, vascular |
| Applicant | Vascular Solutions, Inc. |
| Product code | MGB |
| Received date | May 16, 2003 |
| Decision date | Jun 13, 2003 |
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: