PMA supplement
BP950005 S058: AMPLICOR® HIV-1 MONITOR Test, v1.5; COBAS® AMPLICOR® HIV-1 MONITOR Test, v1.5; COBAS® AmpliPrep/COBAS® AMPLICOR® HIV-1 MONITOR Test, v1.5
FDA PMA supplement · 135 Day Track for 30 Day Notification · Roche Molecular Systems, Inc.
Key facts
| Original PMA | BP950005 |
|---|---|
| Supplement number | S058 |
| Supplement type | 135 Day Track for 30 Day Notification |
| Trade name | AMPLICOR® HIV-1 MONITOR Test, v1.5; COBAS® AMPLICOR® HIV-1 MONITOR Test, v1.5; COBAS® AmpliPrep/COBAS® AMPLICOR® HIV-1 MONITOR Test, v1.5 |
| Generic name | Human immunodeficiency virus (hiv) viral load monitoring test |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | QUM |
| Received date | Dec 12, 2011 |
| Decision date | Oct 26, 2012 |
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: