PMA supplement
P170025 S017: Aptima HBV Quant Assay
FDA PMA supplement · Real-Time Process · Hologic, Inc.
Key facts
| Original PMA | P170025 |
|---|---|
| Supplement number | S017 |
| Supplement type | Real-Time Process |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | Aptima HBV Quant Assay |
| Generic name | Hepatitis Viral B DNA Detection |
| Applicant | Hologic, Inc. |
| Product code | MKT |
| Received date | Dec 14, 2021 |
| Decision date | Feb 25, 2022 |
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: