Identity
- Trade Name
- TENDRIL DX MODEL 1388T & 1388K ENDOCARDIAL PACING LEADS FDA PMA
- Generic Name
- Drug eluting permanent right ventricular (RV) or right atrial (RA) pacemaker electrodes FDA PMA
Identifiers
- PMA Number
- P960013 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 Tendril 1888 Endocardial Pacing Lead is a Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrode, designed for endocardial fixation in cardiac pacing applications. It features a screw-in mechanism and is intended for use with a compatible pulse generator to provide permanent pacing and sensing in either the atrium or ventricle. The lead incorporates a steroid-eluting coating to support tissue integration and long-term stability.
This device is supplied sterile and intended for single-use implantation within a clinical setting. It is classified as a Class III medical device under FDA regulations and has received FDA PMA approval (PMA Number: P960013). The lead is available in two models (1888T and 1888K) and must be used in conjunction with an approved pulse generator. Storage and handling follow standard sterile medical device protocols to ensure integrity prior to implantation.
Frequently asked questions
What are the key differences between the 1888T and 1888K models of the Tendril 1888 Lead, and how do I choose between them?
The Tendril 1888 Lead is available in two models (1888T and 1888K), but the provided data does not specify functional or structural differences between them beyond the model designation. Both are Drug Eluting Permanent Right Ventricular (RV) or Right Atrial (RA) Pacemaker Electrodes with a screw-in fixation mechanism and steroid-eluting coating. Selection should be based on compatibility with the pulse generator you intend to use, as the lead must be paired with an approved device for permanent pacing and sensing. Always verify compatibility with your chosen pulse generator’s specifications.
Is the Tendril 1888 Lead reusable, or is it intended for single-use only?
The Tendril 1888 Lead is explicitly described as intended for single-use implantation within a clinical setting. This designation aligns with standard sterile medical device protocols, ensuring patient safety and sterility during implantation. Reuse is not recommended or supported by the manufacturer.
How should the Tendril 1888 Lead be stored to maintain its sterility and integrity before use?
The lead is supplied sterile, so storage must follow standard sterile medical device protocols to preserve its integrity. This typically includes keeping it in its original, sealed packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by ensuring the packaging remains unopened until immediate pre-procedure preparation.
What type of pulse generator is required to use the Tendril 1888 Lead, and how do I confirm compatibility?
The Tendril 1888 Lead is designed to be used in conjunction with an approved pulse generator to provide permanent pacing and sensing in either the atrium or ventricle. While the data does not list specific compatible generators, compatibility is critical—always verify the lead’s model (1888T or 1888K) against the pulse generator’s specifications or manufacturer guidelines. Abbott Medical’s documentation or technical support should be consulted to confirm pairing.
What regulatory pathway was followed for FDA approval of the Tendril 1888 Lead, and what does this mean for clinicians?
The Tendril 1888 Lead received FDA PMA approval (PMA Number: P960013), which is the highest regulatory pathway for Class III medical devices like endocardial pacing leads. This means the device underwent rigorous clinical evaluation to demonstrate safety and effectiveness before approval. Clinicians should rely on this approval as evidence of the lead’s regulatory compliance, though individual institutions may have additional procurement or clinical protocol requirements.
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.
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_PMA
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA PMA | United States | FDA_PMA | P960013 | Class III | Active |
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Manufacturer
- Manufacturer
- Abbott Medical
Sources (1)
- FDA PMA P960013 24 fields · synced Sep 18, 2026