PMA supplement
P000027 S035: Elecsys free PSA Test System, Biotin remediation
FDA PMA supplement · Normal 180 Day Track · Roche Diagnostics Corp.
Key facts
| Original PMA | P000027 |
|---|---|
| Supplement number | S035 |
| Supplement type | Normal 180 Day Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Elecsys free PSA Test System, Biotin remediation |
| Generic name | Test, prostate specific antigen, free, (noncomplexed) to distinguish prostate cancer from benign conditions |
| Applicant | Roche Diagnostics Corp. |
| Product code | MTG |
| Received date | Nov 27, 2019 |
| Decision date | May 12, 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: