PMA supplement
P100020 S017: COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS
FDA PMA supplement · Panel Track · Roche Molecular Systems, Inc.
Key facts
| Original PMA | P100020 |
|---|---|
| Supplement number | S017 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | COBAS HPV TEST, 240 TESTS; COBAS HPV TEST, 960 TESTS |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Roche Molecular Systems, Inc. |
| Product code | MAQ |
| Received date | Dec 23, 2015 |
| Decision date | Jul 7, 2016 |
| Docket number | 16M-1917 |
| Notice date | Jul 19, 2016 |
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: