PMA supplement
P000021 S044: Dimension® TPSA Flex® reagent cartridge
FDA PMA supplement · 30-Day Notice · Siemens Healthcare Diagnostics
Key facts
| Original PMA | P000021 |
|---|---|
| Supplement number | S044 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Dimension® TPSA Flex® reagent cartridge |
| Generic name | PROSTATE-SPECIFIC ANTIGEN (PSA) FOR MANAGEMENT OF PROSTATE CANCERS |
| Applicant | Siemens Healthcare Diagnostics |
| Product code | LTJ |
| Received date | Nov 18, 2021 |
| Decision date | Dec 20, 2021 |
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: