PMA supplement
P970018 S036: BD PrepStain System
FDA PMA supplement · Normal 180 Day Track No User Fee · Bd Diagnostic Systems
Key facts
| Original PMA | P970018 |
|---|---|
| Supplement number | S036 |
| Supplement type | Normal 180 Day Track No User Fee |
| Reason for the supplement | Location Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | BD PrepStain System |
| Generic name | Processor, cervical cytology slide, automated |
| Applicant | Bd Diagnostic Systems |
| Product code | MKQ |
| Received date | Oct 10, 2017 |
| Decision date | Jun 21, 2018 |
At a glance
- No Expedited review granted
- No Approval order on file
- No 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: