PMA
P880045: OSI TRANSPROBE-1
FDA PMA · DNA-probe, human chromosome · Osi Pharmaceuticals, Inc.
Key facts
| PMA number | P880045 |
|---|---|
| Trade name | OSI TRANSPROBE-1 |
| Generic name | DNA-probe, human chromosome |
| Applicant | Osi Pharmaceuticals, Inc. |
| Product code | MAO |
| Approval date | Oct 3, 1989 |
| Docket number | 89M-0457 |
| Notice date | Nov 14, 1989 |
| FEI number | 3004524429 |
At a glance
- None Supplements
- Oct 3, 1989 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- Yes Withdrawn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: