PMA
P950024: MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
FDA PMA · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes · Medtronic, Inc.
Key facts
| PMA number | P950024 |
|---|---|
| Trade name | MEDTRONIC(R) CAPSURE(R) EPI PACING LEAD MODEL 4695 |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | Medtronic, Inc. |
| Owner/operator | Medtronic, Inc. |
| Product code | NVN |
| Approval date | Sep 6, 1996 |
| Docket number | 97M-0273 |
| Notice date | Jul 8, 1997 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 100–999 Supplements
- Apr 15, 2026 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- No Withdrawn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: