PMA
P930039: MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568
FDA PMA · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes · Medtronic, Inc.
Key facts
| PMA number | P930039 |
|---|---|
| Trade name | MEDTRONIC(R) CAPSUREFIX LEAD MODEL 4068,4067,4568 |
| 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 | Mar 29, 1996 |
| Docket number | 96M-0357 |
| Notice date | Oct 8, 1996 |
| Establishment registration | 2182208 |
| FEI number | 2182208 |
At a glance
- 100–999 Supplements
- Jun 24, 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- No Withdrawn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: