PMA
P040052: MONOPREP PAP TEST
FDA PMA · Processor, cervical cytology slide, automated · Hologic, Inc.
Key facts
| PMA number | P040052 |
|---|---|
| Trade name | MONOPREP PAP TEST |
| Generic name | Processor, cervical cytology slide, automated |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | MKQ |
| Approval date | Mar 3, 2006 |
| Docket number | 06M-0264 |
| Notice date | Jun 26, 2006 |
| Establishment registration | 1222780 |
| FEI number | 1000120743 |
At a glance
- 1–9 Supplements
- Oct 16, 2008 Latest supplement decision
- Yes Withdrawn
- Yes Summary of safety and effectiveness on file
- None 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: