PMA supplement
P110041 S008: ADVIA Centaur and Atellica IM HBsAgII
FDA PMA supplement · 30-Day Notice · Siemens Corp.
Key facts
| Original PMA | P110041 |
|---|---|
| Supplement number | S008 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | ADVIA Centaur and Atellica IM HBsAgII |
| Generic name | Test, Hepatitis B (B Antigen, B Surface Antigen, Be Antigen) |
| Applicant | Siemens Corp. |
| Product code | LOM |
| Received date | Feb 21, 2020 |
| Decision date | Mar 19, 2020 |
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: