PMA
P100042: APTIMA HPV ASSAY
FDA PMA · Kit, rna detection, human papillomavirus · Gen-Probe Incorporated
Key facts
| PMA number | P100042 |
|---|---|
| Trade name | APTIMA HPV ASSAY |
| Generic name | Kit, rna detection, human papillomavirus |
| Applicant | Gen-Probe Incorporated |
| Owner/operator | HOLOGIC, INC. |
| Product code | OYB |
| Approval date | Oct 28, 2011 |
| Docket number | 11M-0792 |
| Notice date | Nov 4, 2011 |
| Establishment registration | 2024800 |
| FEI number | 2024800 |
At a glance
- 10–99 Supplements
- Feb 3, 2026 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- 1–9 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: