PMA
P920015: MEDTRONIC(R) TRANSVENE LEAD SYSTEM
FDA PMA · Permanent defibrillator electrodes · Medtronic, Inc.
Key facts
| PMA number | P920015 |
|---|---|
| Trade name | MEDTRONIC(R) TRANSVENE LEAD SYSTEM |
| Generic name | Permanent defibrillator electrodes |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NVY |
| Approval date | Dec 9, 1993 |
| Docket number | 94M-0063 |
| Notice date | Apr 19, 1994 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 100–999 Supplements
- Aug 19, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 100–999 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: