PMA supplement
P950009 S008: BD FOCALPOINT GS IMAGING SYSTEM
FDA PMA supplement · Panel Track · Bd Diagnostics
Key facts
| Original PMA | P950009 |
|---|---|
| Supplement number | S008 |
| Supplement type | Panel Track |
| Reason for the supplement | Change Design/Components/Specifications/Material |
| Trade name | BD FOCALPOINT GS IMAGING SYSTEM |
| Generic name | READER, CERVICAL CYTOLOGY SLIDE, AUTOMATED |
| Applicant | Bd Diagnostics |
| Product code | MNM |
| Received date | Oct 2, 2007 |
| Decision date | Dec 3, 2008 |
| Docket number | 09M-0016 |
| Notice date | Jan 27, 2009 |
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: