PMA
P940001: GENESA(R) SYSTEM
FDA PMA · Pump, drug administration, closed loop · Gensia, Inc.
Key facts
| PMA number | P940001 |
|---|---|
| Trade name | GENESA(R) SYSTEM |
| Generic name | Pump, drug administration, closed loop |
| Applicant | Gensia, Inc. |
| Product code | MQT |
| Approval date | Sep 12, 1997 |
| Docket number | 98M-0136 |
| Notice date | Mar 4, 1998 |
At a glance
- None Supplements
- Sep 12, 1997 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- Yes Withdrawn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: