PMA supplement
P190028 S009: cobas HPV
FDA PMA supplement · Panel Track · Roche Molecular Systems, Inc.
Key facts
| Original PMA | P190028 |
|---|---|
| Supplement number | S009 |
| Supplement type | Panel Track |
| Reason for the supplement | Labeling Change - Indications/instructions/shelf life/tradename |
| Trade name | cobas HPV |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | MAQ |
| Received date | May 8, 2023 |
| Decision date | May 14, 2024 |
| Docket number | 24M-2536 |
| Notice date | May 31, 2024 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes 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: