PMA
P980024: PATHVYSION HER-2 DNA PROBE KIT
FDA PMA · System, Test, Her-2/Neu, Nucleic Acid Or Serum · Abbott Molecular, Inc.
Key facts
| PMA number | P980024 |
|---|---|
| Trade name | PATHVYSION HER-2 DNA PROBE KIT |
| Generic name | System, Test, Her-2/Neu, Nucleic Acid Or Serum |
| Applicant | Abbott Molecular, Inc. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MVD |
| Approval date | Dec 11, 1998 |
| Docket number | 99M-0034 |
| Notice date | Jan 20, 1999 |
| Establishment registration | 3005248192 |
| FEI number | 3005248192 |
At a glance
- 10–99 Supplements
- Mar 18, 2022 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: