PMA
P890039: MASTRO SAVVI SERIES 300 VDD PACING SYSTEM
FDA PMA · Implantable pacemaker Pulse-generator · Cardiac Control Systems, Inc.
Key facts
| PMA number | P890039 |
|---|---|
| Trade name | MASTRO SAVVI SERIES 300 VDD PACING SYSTEM |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Cardiac Control Systems, Inc. |
| Product code | DXY |
| Approval date | Sep 25, 1990 |
| Docket number | 90m-0333 |
| Notice date | Nov 2, 1990 |
At a glance
- 10–99 Supplements
- Nov 9, 1998 Latest supplement decision
- No Withdrawn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: