PMA supplement
P900059 S004: ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED
FDA PMA supplement · Panel Track · Molecular Biosystems, Inc.
Key facts
| Original PMA | P900059 |
|---|---|
| Supplement number | S004 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | ALBUNEX(R) ALBUMIN (HUMAN) 5%, SONICATED |
| Generic name | Contrast media, ultrasound |
| Applicant | Molecular Biosystems, Inc. |
| Product code | MJS |
| Received date | Sep 3, 1996 |
| Decision date | Jun 17, 1997 |
| Docket number | 97M-0392 |
| Notice date | Sep 23, 1997 |
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: