EFH-16 - S 60-J

This **Diplos Model 03** is specifically designed for patients requiring **single-chamber pacing** to manage **bradycardia or conduction disorders**. Unlike cardiac resynchronization therapy (CRT) pacemakers, it does not provide biventricular pacing, meaning it does not coordinate both the left and right ventricles. Instead, it delivers electrical impulses to a single heart chamber to regulate the heart’s rhythm independently.

The **Diplos Model 03** is **sterile and intended for single-use implantation only**. This ensures patient safety and compliance with sterile medical device protocols, as reuse could compromise sterility and integrity.

The **Diplos Model 03** is available in **four model variants**: **EFH-16; S 60-K; S 60-J; and S 60-S**. While the exact technical differences between these models are not specified in the data, they likely represent variations in programming, pacing algorithms, or battery specifications tailored for different clinical needs. Selection should be based on physician preference and patient-specific requirements.

Since the **Diplos Model 03** is **sterile and single-use**, it must be stored in a **controlled environment** following standard sterile medical device protocols. This includes protection from moisture, contamination, and physical damage. The packaging should remain intact until implantation, and storage conditions should comply with manufacturer guidelines to preserve sterility and performance.

This pacemaker was approved through the **FDA’s Premarket Approval (PMA) process**, specifically under **PMA number P820076**. The PMA pathway is reserved for high-risk medical devices like Class III implants, ensuring rigorous evaluation of safety and effectiveness before market authorization. Clinicians can trust that this device has undergone thorough review by the FDA, though final implantation decisions should still align with patient-specific clinical guidelines.