PMA
P020002: THINPREP (R) IMAGING SYSTEM
FDA PMA · READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED · Hologic, Inc.
Key facts
| PMA number | P020002 |
|---|---|
| Trade name | THINPREP (R) IMAGING SYSTEM |
| Generic name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | MNM |
| Approval date | Jun 6, 2003 |
| Docket number | 03M-0339 |
| Notice date | Jul 30, 2003 |
| Establishment registration | 1222780 |
| FEI number | 1000120743 |
At a glance
- 10–99 Supplements
- Jun 2, 2015 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- No Withdrawn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: