MODEL4553 Micro-Pace, Dual-Chamber, Ddd Temporary Cardiac Pacemaker

No FDA recalls found in the data synced 6 Oct 2026.

Trade Name

Model 4553 Dual Cham. Ddd Temp.cardiac Pacemaker

Generic Name

Generator, pulse, pacemaker, external programmable (for electrophysiological studies only)

PMA Number

P920032 ↗

FDA Product Code

JOQ

Device Class

Class II

Regulation

21 CFR Part 870.1750

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

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• Temporary Pacemaker Extension Cable, Models 5235, 5235A, 5235V, Temporary Pacemaker Surgical Extension Cable, Models 528

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  FDA 510(k) K890988 Active Cleared 25 Aug 1989

• Pace Implant. Lead/Tined/Atrial/J/Model 3290

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  FDA 510(k) K864153 Active Cleared 6 Jan 1987

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• What is the primary clinical setting where the Model 4553 is intended to be used, and why is this important for its operation?

  The Model 4553 is designed for use in controlled clinical environments like cardiac catheterization labs or electrophysiology labs. This setting is critical because it ensures proper sterile handling of electrode leads (which are required for use with this device) and allows for external programming, which is essential for temporary cardiac pacing during electrophysiological studies.

• Is the Model 4553 a single-use or reusable device, and what does this mean for its maintenance and cost?

  The Model 4553 is a reusable device, meaning it is intended for repeated use in clinical settings after proper cleaning and maintenance. This design reduces per-patient costs compared to single-use devices and allows for consistent performance across multiple procedures, provided storage and handling follow the manufacturer’s guidelines to maintain functionality and patient safety.

• What type of electrode leads are required for use with the Model 4553, and why is sterility important in this context?

  The Model 4553 requires sterile electrode leads for proper operation, as it is designed for temporary cardiac pacing during invasive procedures. Sterility is critical because these leads are inserted into the patient’s body, and contamination could lead to infection or compromise patient safety during electrophysiological studies or temporary bradycardia management.

• How does the dual-chamber, demand-mode (DDD) feature of the Model 4553 benefit patients experiencing temporary heart rhythm issues?

  The dual-chamber, DDD (demand-mode) feature of the Model 4553 synchronizes pacing pulses with the patient’s natural atrial and ventricular activity. This ensures more physiologic heart rhythm regulation compared to single-chamber devices, reducing the risk of irregularities like atrial fibrillation or ventricular asynchrony during temporary bradycardia or conduction disturbances in electrophysiological studies.

• What regulatory pathway does the Model 4553 follow, and what does this mean for healthcare providers considering its use?

  The Model 4553 follows the FDA Premarket Approval (PMA) pathway, indicated by the PMA number (P920032). This means it has undergone rigorous review by the FDA to ensure safety and effectiveness for its intended use in electrophysiological studies. Healthcare providers should confirm compliance with the manufacturer’s guidelines and storage instructions to maintain regulatory and clinical standards.