PMA supplement
P000012 S026: COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST
FDA PMA supplement · 135 Review Track For 30-Day Notice · Roche Molecular Systems, Inc.
Key facts
| Original PMA | P000012 |
|---|---|
| Supplement number | S026 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | COBAS AMPLIPREP/COBAS AMPLICOR HCV TEST |
| Generic name | Assay, hybridization and/or nucleic acid amplification for detection of hepatitis c rna,hepatitis c virus |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | MZP |
| Received date | Aug 30, 2010 |
| Decision date | May 24, 2011 |
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: