PMA
P950009: AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM
FDA PMA · READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED · Bd Diagnostics
Key facts
| PMA number | P950009 |
|---|---|
| Trade name | AUTOPAP(R) 300 QC AUTOMATIC PAP SCREENER/QC SYSTEM |
| Generic name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
| Applicant | Bd Diagnostics |
| Owner/operator | Becton Dickinson and Company |
| Product code | MNM |
| Approval date | Sep 29, 1995 |
| Docket number | 96M-0332 |
| Notice date | Sep 23, 1996 |
| Establishment registration | 1119779 |
| FEI number | 1119779 |
At a glance
- 10–99 Supplements
- Jul 11, 2022 Latest supplement decision
- No Withdrawn
- No 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: