PMA supplement
P940005 S002: HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD
FDA PMA supplement · Normal 180 Day Track · Advanced Technology Laboratories, Inc.
Key facts
| Original PMA | P940005 |
|---|---|
| Supplement number | S002 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | HDI 3000 ULTRASOUND SYSTEM WITH L12-5 SCANHEAD |
| Generic name | System, imaging, pulsed doppler, ultrasonic |
| Applicant | Advanced Technology Laboratories, Inc. |
| Product code | IYN |
| Received date | May 30, 1997 |
| Decision date | Jul 21, 1998 |
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: