PMA
P000052: GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM
FDA PMA · Intravascular radiation delivery system · Guidant Corp.
Key facts
| PMA number | P000052 |
|---|---|
| Trade name | GALILEO INTRAVASCULAR RADIOTHERAPY SYSTEM |
| Generic name | Intravascular radiation delivery system |
| Applicant | Guidant Corp. |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | MOU |
| Approval date | Nov 2, 2001 |
| Docket number | 01M-0508 |
| Notice date | Nov 14, 2001 |
| Establishment registration | 2024168 |
| FEI number | 2024168 |
At a glance
- 10–99 Supplements
- Jun 10, 2004 Latest supplement decision
- Yes Withdrawn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: