Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads
FDA PMAClass III (US FDA PMA)
Identity
- Trade Name
- PASSIVE PLUS DX ENDOCARDIAL STEROID ELUTING, PASSIVE-FIXATION PACING LEADS FDA PMA
- Generic Name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes FDA PMA
Identifiers
- PMA Number
- P960030 FDA PMA
- FDA Product Code
- NVN FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads are Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes, designed for permanent pacing and sensing in either the atrium or ventricle. These leads incorporate a steroid-eluting coating to reduce pacing thresholds and improve long-term performance, while passive fixation ensures stable electrode placement within the heart.
These leads are supplied sterile and intended for single-use implantation in a clinical setting. They are compatible with a compatible pulse generator and are classified as Class III devices under FDA regulations, with approval granted under PMA number P960030. Models include 1342T (atrial), 1343K (atrial), 1345K (ventricular), and 1346T (ventricular), each designed for specific anatomical applications within the right side of the heart.
Frequently asked questions
What anatomical locations are these leads designed for implantation, and how do the models differ?
These leads are designed for permanent pacing and sensing in the right atrium (RA) or right ventricle (RV) of the heart. The models differ by anatomical application: the **1342T** and **1343K** are for atrial placement, while the **1345K** and **1346T** are for ventricular placement. The distinction ensures compatibility with the specific chamber’s anatomy for stable electrode positioning.
Are these leads reusable, or are they intended for single-use only?
The Passive Plus DX Endocardial Steroid Eluting, Passive-Fixation Pacing Leads are explicitly supplied **sterile** and intended for **single-use implantation** in a clinical setting. Reuse is not recommended or supported by the manufacturer.
What is the purpose of the steroid-eluting coating on these leads, and how does it benefit the patient?
The steroid-eluting coating is designed to **reduce pacing thresholds** and **improve long-term performance** of the leads. This helps ensure more reliable and efficient pacing over time, potentially lowering the risk of complications like lead dislodgment or elevated energy requirements for stimulation.
How should these leads be stored before use, and what precautions should be taken?
Since the leads are supplied **sterile**, they should be stored in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures. The packaging must remain intact until immediate use to maintain sterility and prevent contamination.
What type of pulse generator is required for compatibility with these leads?
These leads are designed to be used **in combination with a compatible pulse generator**. While the specific models (1342T, 1343K, 1345K, 1346T) are optimized for right atrial or ventricular pacing, the exact pulse generator compatibility should be verified with the manufacturer’s documentation or technical specifications, as not all generators may support their features.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Passive Plus Dx Endocardial Steroid Eluting, Passive-fixation Pacing ..., Cardiac Rhythm Management Leads | Abbott, Passive Plus Dx Endocardial, Steroid Eluting, Passive Fixation Pacing ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P960030 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P960030 24 fields · synced Sep 18, 2026