Acuity Steerable Stylet Accessory

No FDA recalls on record, checked 6 Oct 2026.

Trade Name

Acuity Steerable Lead System

Generic Name

Drug eluting permanent left ventricular (lv) pacemaker electrode

PMA Number

P050046 ↗

FDA Product Code

OJX

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

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See all devices from Guidant Corp. →

• What is the ACUITY Steerable Stylet Accessory used for?

  The ACUITY Steerable Stylet Accessory is used to assist in the delivery and positioning of the ACUITY Steerable lead models 4554, 4555, and 4556 during implantation. It is not a lead itself but a tool designed to facilitate the placement of these specific steroid-eluting, dual-electrode pace/sense leads into the coronary veins for chronic left-ventricular pacing and sensing.

• Is the ACUITY Steerable Stylet Accessory sterile or reusable?

  The ACUITY Steerable Stylet Accessory is supplied non-sterile and is intended for single use only. It must not be reused or resterilized, as doing so could compromise its functionality and patient safety. Users should follow the manufacturer’s instructions for handling and disposal.

• Which lead models is the ACUITY Steerable Stylet Accessory compatible with?

  The ACUITY Steerable Stylet Accessory is specifically designed for use with ACUITY Steerable lead models 4554, 4555, and 4556. These leads are transvenous, steroid-eluting, dual-electrode pace/sense devices intended for chronic left-ventricular pacing and sensing via the coronary veins when used with a compatible pulse generator.