Versatrax Model 7000 Universal A-V Pulse Generator

No FDA recalls found in the data synced 22 Oct 2026.

Generic Name

Implantable pulse generator, pacemaker (non-CRT)

PMA Number

P820003 ↗

FDA Product Code

LWP

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

PMA Supplement

S019

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See all devices from Medtronic Cardiac Rhythm Disease Management →

• What clinical condition is the Versatrax Model 7000 designed to address, and how does it work?

  The Versatrax Model 7000 is designed to manage **bradycardia** (slow heart rate) and **conduction disorders**, where the heart’s electrical signals are improperly timed or absent. It functions as an **implantable pacemaker** by delivering timed electrical impulses to the heart muscle, ensuring proper **atrial-ventricular (A-V) sequencing** to maintain a regular heartbeat. This autonomous device compensates for the heart’s inability to regulate its own rhythm independently.

• Is the Versatrax Model 7000 intended for reuse, or is it single-use only?

  The Versatrax Model 7000 is **intended for single-patient use only**, as explicitly stated in its labeling. This aligns with standard practices for implantable devices to ensure sterility and patient safety, preventing cross-contamination or device degradation from repeated use.

• How many different sizes or configurations are available for the Versatrax Model 7000, and how are they identified?

  The Versatrax Model 7000 is available in **multiple sizes and configurations**, each identified by unique **registration numbers** (e.g., 1721676, 2017865, etc.). These variations likely accommodate different patient anatomies or clinical needs, though specific dimensions or features are not detailed in the provided data. The device’s compatibility with MRI environments is also noted in its labeling for certain models.

• What storage and handling precautions should be taken for the Versatrax Model 7000 before implantation?

  The Versatrax Model 7000 is supplied **sterile**, so it must be stored and handled according to **standard sterile implantable device protocols** to maintain integrity until use. This includes protecting it from contamination, moisture, or physical damage, as well as adhering to manufacturer guidelines for shelf life and environmental conditions (e.g., temperature, humidity). Always refer to the included labeling for precise storage instructions.

• What regulatory pathway was followed for the Versatrax Model 7000, and when was it authorized?

  The Versatrax Model 7000 was authorized through the **FDA’s Premarket Approval (PMA) process**, with the primary application (PMA #P820003) received on **December 24, 1985**, and approved on **March 27, 1986**. This pathway is used for high-risk, Class III devices like implantable pulse generators. The device is also associated with **supplement S025**, indicating potential updates or modifications to the original approval.