PMA
P820003: VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR
FDA PMA · Implantable pulse generator, pacemaker (non-CRT) · Medtronic Cardiac Rhythm Disease Management
Key facts
| PMA number | P820003 |
|---|---|
| Trade name | VERSATRAX MODEL 7000 UNIVERSAL A-V PULSE GENERATOR |
| Generic name | Implantable pulse generator, pacemaker (non-CRT) |
| Applicant | Medtronic Cardiac Rhythm Disease Management |
| Owner/operator | Medtronic, Inc. |
| Product code | LWP |
| Approval date | Nov 16, 1982 |
| Docket number | 82M-0377 |
| Notice date | Jan 7, 1983 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 100–999 Supplements
- Mar 20, 2025 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- No Withdrawn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: