PMA
P080014: CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT
FDA PMA · KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS · Hologic, Inc.
Key facts
| PMA number | P080014 |
|---|---|
| Trade name | CERVISTA HPV HR AND GENFIND DNA EXTRACTION KIT |
| Generic name | KIT, DNA DETECTION, HUMAN PAPILLOMAVIRUS |
| Applicant | Hologic, Inc. |
| Owner/operator | HOLOGIC, INC. |
| Product code | MAQ |
| Approval date | Mar 12, 2009 |
| Docket number | 09M-0299 |
| Notice date | Jun 30, 2009 |
| Establishment registration | 1222780 |
| FEI number | 1000120743 |
At a glance
- 10–99 Supplements
- Nov 15, 2018 Latest supplement decision
- No Withdrawn
- Yes Summary of safety and effectiveness on file
- None UDI device identifiers (GUDID)
- None MAUDE adverse event reports
- None Recall events
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About PMA approvals
Premarket approval (PMA) is the FDA's most stringent review pathway, required for most Class III devices that support or sustain life or present a potentially unreasonable risk.
Source: U.S. Food and Drug Administration (FDA), Premarket Approval (PMA) database · Source date: