PMA supplement
P780012 S014: AXSYM HAVAB 2.0
FDA PMA supplement · Special (Immediate Track) · Abbott Laboratories
Key facts
| Original PMA | P780012 |
|---|---|
| Supplement number | S014 |
| Supplement type | Special (Immediate Track) |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | AXSYM HAVAB 2.0 |
| Generic name | Hepatitis a test (antibody and igm antibody) |
| Applicant | Abbott Laboratories |
| Product code | LOL |
| Received date | Jul 22, 2004 |
| Decision date | Jul 30, 2004 |
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: