PMA
P050043: FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH
FDA PMA · Device, hemostasis, vascular · Morris Innovative Research, Inc.
Key facts
| PMA number | P050043 |
|---|---|
| Trade name | FEMORAL INTRODUCER SHEATH AND HEMOSTASIS (FISH) DEVICE 5,6, AND 8 FRENCH |
| Generic name | Device, hemostasis, vascular |
| Applicant | Morris Innovative Research, Inc. |
| Product code | MGB |
| Approval date | Aug 20, 2007 |
| Docket number | 07M-0344 |
| Notice date | Sep 18, 2007 |
At a glance
- 1–9 Supplements
- Sep 19, 2018 Latest supplement decision
- No Withdrawn
- Yes 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: