PMA
P920004: VASOSEAL (TM)
FDA PMA · Device, hemostasis, vascular · St. Jude Medical, Inc.
Key facts
| PMA number | P920004 |
|---|---|
| Trade name | VASOSEAL (TM) |
| Generic name | Device, hemostasis, vascular |
| Applicant | St. Jude Medical, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MGB |
| Approval date | Sep 29, 1995 |
| Docket number | 95m-0394 |
| Notice date | Dec 15, 1995 |
| Establishment registration | 3012179728 |
| FEI number | 1000526851 |
At a glance
- 10–99 Supplements
- Jan 11, 2008 Latest supplement decision
- Yes Withdrawn
- No Summary of safety and effectiveness on file
- None 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: