PMA
P210029: Aptima CMV Quant Assay
FDA PMA · Cytomegalovirus (cmv) dna quantitative assay · Hologic, Inc.
Key facts
| PMA number | P210029 |
|---|---|
| Trade name | Aptima CMV Quant Assay |
| Generic name | Cytomegalovirus (cmv) dna quantitative assay |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | PAB |
| Approval date | May 9, 2022 |
| Docket number | 22M-2065 |
| Notice date | Sep 1, 2022 |
| Establishment registration | 2024800 |
| FEI number | 2024800 |
At a glance
- 1–9 Supplements
- Oct 23, 2024 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- No Withdrawn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: