PMA supplement
P950039 S036: ThinPrep Integrated Imager
FDA PMA supplement · Panel Track · Hologic, Inc.
Key facts
| Original PMA | P950039 |
|---|---|
| Supplement number | S036 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | ThinPrep Integrated Imager |
| Generic name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
| Applicant | Hologic, Inc. |
| Product code | MNM |
| Received date | Jul 31, 2017 |
| Decision date | Apr 18, 2018 |
| Docket number | 18M-1580 |
| Notice date | May 7, 2018 |
At a glance
- No Expedited review granted
- Yes Approval order on file
- Yes Summary of safety and effectiveness on file
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA supplements
A PMA supplement asks FDA to approve a change to a device that already holds a premarket approval: a new indication, a design or labeling change, a manufacturing site or process change.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: