PMA
P860035: TITRATOR MODEL 10K
FDA PMA · CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE · Ivac Corporation
Key facts
| PMA number | P860035 |
|---|---|
| Trade name | TITRATOR MODEL 10K |
| Generic name | CONTROLLER, CLOSED-LOOP, BLOOD-PRESSURE |
| Applicant | Ivac Corporation |
| Product code | LSX |
| Approval date | Dec 17, 1987 |
| Docket number | 88M-0005 |
| Notice date | Feb 10, 1988 |
At a glance
- 1–9 Supplements
- Mar 10, 1993 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: