Identity
- Trade Name
- Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software FDA PMA
- Generic Name
- Implantable pulse generator, pacemaker (non-CRT) FDA PMA
Identifiers
- PMA Number
- P140033 FDA PMA
- FDA Product Code
- LWP FDA PMA
Classification
- Device Class
- Class III FDA PMA
- Advisory Committee
- Cardiovascular FDA PMA
- FDA Decision
- APPR Approved FDA PMA
The Tendril MRI Lead (Model LPA 1200M) is a 7.9 French, transvenous, steroid-eluting, bipolar, IS-1 compliant active fixation lead. It is designed for permanent sensing and pacing in either the right atrium or right ventricle, intended for use in combination with an MR Conditional pacemaker system. This lead is specifically engineered for stable fixation in patients where passive leads may be unstable, including those with abnormal, surgically altered, or excised atrial appendages.
The Tendril MRI Lead is supplied sterile and intended for single-use implantation. It is MR Conditional, meaning it is safe for use in the MRI environment when part of a complete MR Conditional pacing system and used according to specified instructions. The lead is authorized under FDA PMA (P140033) and is categorized under product code LWP. Storage and handling must comply with standard sterile medical device protocols.
Frequently asked questions
What types of patients might benefit from using the Tendril MRI Lead instead of a passive fixation lead?
The Tendril MRI Lead is designed for patients where passive leads may be unstable, particularly those with abnormal, surgically altered, or excised atrial appendages. Its active fixation mechanism provides more stable placement in challenging anatomical conditions, ensuring reliable sensing and pacing in the right atrium or right ventricle.
Is the Tendril MRI Lead suitable for use in an MRI environment, and if so, what conditions apply?
Yes, the Tendril MRI Lead is **MR Conditional**, meaning it can be safely used in an MRI environment *only* when part of a complete MR Conditional pacing system and used strictly according to the provided MRI Procedure Information document. This ensures compatibility with MRI scans while maintaining pacing functionality.
How is the Tendril MRI Lead supplied, and what are the implications for clinical use?
The Tendril MRI Lead (Model LPA 1200M) is supplied sterile and intended for **single-use implantation only**. This eliminates the need for reprocessing and reduces infection risks, aligning with standard sterile medical device protocols for implantation.
What is the French size of the Tendril MRI Lead, and how does this relate to its placement?
The Tendril MRI Lead has a **7.9 French** diameter, which is relatively standard for transvenous leads. This size allows for safe passage through the venous system while providing sufficient strength for active fixation in the right atrium or right ventricle, ensuring stable sensing and pacing.
What regulatory pathway was followed for the Tendril MRI Lead’s approval, and what does this mean for clinicians?
The Tendril MRI Lead was approved via the **FDA PMA (P140033)** pathway, which is a premarket approval process for higher-risk medical devices. This means it has undergone rigorous clinical evaluation to ensure safety and effectiveness, giving clinicians confidence in its performance for permanent pacing applications in eligible patients.
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: Tendril Pacing Leads | Abbott, Tendril Pacing Leads | Abbott, MRI Compatibility - ABBOTT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P140033 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P140033 24 fields · synced Sep 18, 2026