Poly-Safe A-Track Pacing Leads

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

Full name

Poly-Safe(Tm) a-Track(Tm) Pacing Leads

Trade Name

Mastro Savvi Series 300 Vdd Pacing System

Generic Name

implantable pacemaker Pulse-generator

PMA Number

P890039 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

• CCS Implantable Maestro Series 100/200 Pacemaker

  Class III

  FDA 510(k) K874158 Active Cleared 29 Dec 1987

• Maestro Series 100/200 Single Chamber Pacemaker

  Class III

  FDA 510(k) K884023 Active Cleared 17 Oct 1988

• Maestro II Series 200 Models 235 and 227 Cardiac Pacemaker

  Class III

  FDA 510(k) K950210 Active Cleared 3 May 1995

• CCS Implantable Maestro 106/206/210 Cardiac Pacemaker

  Class III

  FDA 510(k) K853471 Active Cleared 24 Feb 1986

• CCS Model SJ-103 Implantable Atrial

  Class III

  FDA 510(k) K831529 Active Cleared 30 Jun 1983

• Maestro Series 100/200 Cardiac Single Chamber Pacemaker

  Class III

  FDA 510(k) K904941 Active Cleared 3 Jan 1991

See all devices from Cardiac Control Systems, Inc. →

• Are these pacing leads intended for use in patients with specific heart conditions beyond bradycardia, or are they limited to conduction disorders only?

  The Poly-Safe A-Track Pacing Leads are designed for **cardiac rhythm management**, specifically to deliver electrical stimulation for patients with **bradycardia or conduction disorders**. While the description emphasizes bradycardia and conduction issues, the broader context of an **implantable pacemaker pulse-generator** implies they may also support pacing needs in related arrhythmias where cardiac coordination is compromised. Always refer to the full labeling for precise indications.

• How should the Poly-Safe A-Track Pacing Leads be prepared for use in the operating room, given they are non-sterile?

  Since these leads are **non-sterile**, they must undergo **sterilization prior to use** as outlined in the manufacturer’s instructions. This ensures safety and compliance with medical device handling protocols before surgical implantation. The specific sterilization method (e.g., ethylene oxide, gamma irradiation) should be confirmed in the accompanying documentation.

• Can these leads be reused across multiple patients, or are they intended for single-use only?

  The Poly-Safe A-Track Pacing Leads are **reusable components** within the **MASTRO SAVVI Series 300 VDD Pacemaker System**. They are designed for implantation in individual patients but may be reused after proper cleaning, sterilization, and adherence to the manufacturer’s reprocessing guidelines. Reuse is contingent on maintaining sterility and functionality as specified in the instructions.

• What storage conditions are required for these leads to maintain their integrity before use?

  While the data does not specify exact storage conditions, reusable medical devices like these typically require **clean, dry, and protected environments** to prevent contamination or damage. The manufacturer’s instructions should detail temperature, humidity, and packaging requirements to ensure the leads remain functional until sterilization and use. Always follow these guidelines to avoid compromising performance.

• Are there any limitations or considerations regarding the use of these leads in patients who require MRI scans?

  The Poly-Safe A-Track Pacing Leads are **compatible for use in MRI environments**, as noted in the system’s design. However, compatibility does not imply unrestricted use—specific MRI safety protocols must be followed, including adherence to the **MASTRO SAVVI Series 300 VDD Pacemaker System’s MRI guidelines**. Always verify the latest safety information from the manufacturer, as MRI procedures for pacemaker leads can vary based on scanner strength and patient-specific factors.