PMA
P230003: Alinity m HR HPV
FDA PMA · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS · Abbott Molecular, Inc.
Key facts
| PMA number | P230003 |
|---|---|
| Trade name | Alinity m HR HPV |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Abbott Molecular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MAQ |
| Approval date | Nov 1, 2023 |
| Docket number | 23M-4997 |
| Notice date | Nov 16, 2023 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 10–99 Supplements
- Sep 2, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 10–99 UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: