PMA supplement
P900059 S003: ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES
FDA PMA supplement · Normal 180 Day Track · Molecular Biosystems, Inc.
Key facts
| Original PMA | P900059 |
|---|---|
| Supplement number | S003 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ALBUNEX(R) ECHOCARDIOGRAPHY CONTRAST MICROSPHERES |
| Generic name | Contrast media, ultrasound |
| Applicant | Molecular Biosystems, Inc. |
| Product code | MJS |
| Received date | Jun 5, 1995 |
| Decision date | Aug 28, 1995 |
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: