PMA
P780011: MINI BALLOON
FDA PMA · Device, Vascular, for Promoting Embolization · Bd Becton Dickinson Vacutainer Systems Preanalytic
Key facts
| PMA number | P780011 |
|---|---|
| Trade name | MINI BALLOON |
| Generic name | Device, Vascular, for Promoting Embolization |
| Applicant | Bd Becton Dickinson Vacutainer Systems Preanalytic |
| Owner/operator | Becton Dickinson and Company |
| Product code | KRD |
| Approval date | May 15, 1980 |
| Establishment registration | 2243072 |
| FEI number | 2243072 |
At a glance
- 10–99 Supplements
- Oct 30, 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- Yes Withdrawn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: