PMA
P160044: ABBOTT REALTIME CMV
FDA PMA · Cytomegalovirus (cmv) dna quantitative assay · Abbott Molecular
Key facts
| PMA number | P160044 |
|---|---|
| Trade name | ABBOTT REALTIME CMV |
| Generic name | Cytomegalovirus (cmv) dna quantitative assay |
| Applicant | Abbott Molecular |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | PAB |
| Approval date | May 18, 2017 |
| Docket number | 17M-3200 |
| Notice date | Jun 1, 2017 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 1–9 Supplements
- Jan 13, 2023 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- No Withdrawn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: