PMA
P960030: PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS
FDA PMA · Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes · ABBOTT MEDICAL
Key facts
| PMA number | P960030 |
|---|---|
| Trade name | PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS |
| Generic name | Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes |
| Applicant | ABBOTT MEDICAL |
| Owner/operator | ABBOTT LABORATORIES |
| Product code | NVN |
| Approval date | Jan 29, 1998 |
| Docket number | 98M-0605 |
| Notice date | Aug 12, 1998 |
| Establishment registration | 1415939 |
| FEI number | 1415939 |
At a glance
- 10–99 Supplements
- Jun 26, 2026 Latest supplement decision
- No Withdrawn
- No Summary of safety and effectiveness on file
- 1–9 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: