PMA supplement
P890064 S035: Digene HC2 HPV DNA Test / Digene HC2 High Risk HPV DNA Test
FDA PMA supplement · 30-Day Notice · Qiagen Gaithersburg, Inc.
Key facts
| Original PMA | P890064 |
|---|---|
| Supplement number | S035 |
| Supplement type | 30-Day Notice |
| Reason for the supplement | Process Change - Manufacturer/Sterilizer/Packager/Supplier |
| Trade name | Digene HC2 HPV DNA Test / Digene HC2 High Risk HPV DNA Test |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Qiagen Gaithersburg, Inc. |
| Product code | MAQ |
| Received date | Nov 30, 2017 |
| Decision date | Dec 21, 2017 |
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: