PMA supplement
P160037 S001: BD Onclarity HPV Assay, BD Viper LT System
FDA PMA supplement · 135 Review Track For 30-Day Notice · Becton, Dickinson and Company
Key facts
| Original PMA | P160037 |
|---|---|
| Supplement number | S001 |
| Supplement type | 135 Review Track For 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | BD Onclarity HPV Assay, BD Viper LT System |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Becton, Dickinson and Company |
| Product code | MAQ |
| Received date | Apr 27, 2018 |
| Decision date | Mar 26, 2019 |
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: