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• • Terminated Z-2235-2009 FDA Unclassified (pre-2012) ·initiated 23 Sep 2008 ·on shared PMA P950029

  Analysis showed that the screwdriver was not fully inserted in the setscrew's hex cavity, which damaged the setscrew.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Trade Name

Chorus Rm Model 7034 Dddr Pacemaker Incl. Opus Rm Model 4534 Ssir Pacemaker

Generic Name

implantable pacemaker Pulse-generator

FDA applicant

MicroPort CRM S.r.l.

PMA Number

P950029 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

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• What types of cardiac conditions is the Chorus RM Model 7034 pacemaker designed to address, and how does it differ from single-chamber pacing solutions?

  The Chorus RM Model 7034 is specifically designed for **dual-chamber and atrial-tracking pacing**, addressing conditions like symptomatic AV block, bundle branch block, sinus node dysfunction, bradycardia-tachycardia syndrome, and vasovagal syndromes. Unlike single-chamber pacemakers, it maintains **atrioventricular (AV) synchrony**, ensuring coordinated atrial and ventricular contractions to optimize cardiac output. This is particularly beneficial for patients with conduction disorders requiring both rate and AV timing adjustments, such as AV block or pacemaker syndrome (VVI intolerance).

• Is this device intended for temporary or chronic cardiac pacing, and what programming capabilities does it include?

  This device is **exclusively for chronic cardiac pacing** and is not intended for temporary use. It features an **IBM-compatible microcomputer** with **CSO 2.46 programming software**, enabling rate-adaptive pacing and dual-chamber modes. This allows clinicians to adjust pacing rates based on patient activity (e.g., increased ventilation) while maintaining AV synchrony, improving overall cardiac function for eligible conditions.

• How is the Chorus RM Model 7034 supplied, and what components are included in the system?

  The device is supplied as a **reusable, implantable system** paired with a **CPR1 programming head** for remote adjustments. It includes the **Chorus RM Model 7034 DDDR pacemaker** and the **Opus RM Model 4534 SSIR pacemaker** (a compatible lead system), forming a complete solution for dual-chamber pacing. The system requires surgical implantation and is not disposable.

• What storage or handling requirements should be followed for this device before implantation?

  While the device data does not specify exact storage conditions, as a **sterile, implantable medical device**, the Chorus RM Model 7034 should be stored in its original packaging until use to prevent contamination. It is critical to follow manufacturer guidelines for **pre-implantation preparation**, including ensuring the device remains dry and protected from physical damage. The CPR1 programming head may require separate handling per instructions.