PMA
P880026: ABBOTT ER-ICA MONOCLONAL
FDA PMA · KIT, ASSAY, ESTROGEN RECEPTOR · Abbott Laboratories
Key facts
| PMA number | P880026 |
|---|---|
| Trade name | ABBOTT ER-ICA MONOCLONAL |
| Generic name | KIT, ASSAY, ESTROGEN RECEPTOR |
| Applicant | Abbott Laboratories |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | LPJ |
| Approval date | Sep 30, 1988 |
| Docket number | 88M-0352 |
| Notice date | Dec 2, 1988 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- None Supplements
- Sep 30, 1988 Latest supplement decision
- Yes Withdrawn
- No 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: