PMA
P940031: VIGOR(TM) DR PACEMAKER SYSTEM
FDA PMA · Implantable pacemaker Pulse-generator · Boston Scientific
Key facts
| PMA number | P940031 |
|---|---|
| Trade name | VIGOR(TM) DR PACEMAKER SYSTEM |
| Generic name | Implantable pacemaker Pulse-generator |
| Applicant | Boston Scientific |
| Owner/operator | Boston Scientific Corporation |
| Product code | DXY |
| Approval date | Jun 21, 1995 |
| Docket number | 96M-0451 |
| Notice date | Nov 29, 1996 |
| Establishment registration | 2124215 |
| FEI number | 2124215 |
At a glance
- 10–99 Supplements
- Apr 2, 2021 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 10–99 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: