PMA
P940005: ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM
FDA PMA · System, imaging, pulsed doppler, ultrasonic · Advanced Technology Laboratories, Inc.
Key facts
| PMA number | P940005 |
|---|---|
| Trade name | ULTRAMARK 9 HIGH DEFINITION IMAGING UULTRASOUND SYSTEM |
| Generic name | System, imaging, pulsed doppler, ultrasonic |
| Applicant | Advanced Technology Laboratories, Inc. |
| Product code | IYN |
| Approval date | Apr 11, 1996 |
| Docket number | 96M-0450 |
| Notice date | Nov 29, 1996 |
At a glance
- 1–9 Supplements
- Jul 21, 1998 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- Yes Withdrawn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: