CCS Model SJ-103 Implantable Atrial

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

510(k) Number

K831529 ↗

FDA Product Code

DTB

Device Class

Class III

Regulation

21 CFR Part 870.3680

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• 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

• Maestro Series 100/200 Cardiac Single Chamber Pacemaker

  Class III

  FDA 510(k) K904941 Active Cleared 3 Jan 1991

• Maestro Model 119 Single-Chamber Pacemaker

  Class III

  FDA 510(k) K880422 Active Cleared 31 Mar 1988

See all devices from Cardiac Control Systems, Inc. →

• What is the primary purpose of the CCS Model SJ-103 Implantable Atrial device, and how does it function in the body?

  The CCS Model SJ-103 Implantable Atrial is designed as a permanent pacemaker electrode specifically for implantation in the atrial chamber of the heart. Its function is to deliver electrical pacing stimuli to regulate cardiac rhythm in patients experiencing atrial conduction disorders or bradycardia—essentially ensuring the heart beats at an appropriate rate when its natural electrical system fails.

• Is this device intended for reuse, or is it meant to be implanted once and left in place permanently?

  The CCS Model SJ-103 is intended for single-use implantation—it is surgically placed by a healthcare professional and remains in the body as a permanent pacemaker electrode. It is not designed for removal or reuse after initial implantation.

• How is the device supplied, and what precautions should be taken during handling?

  The CCS Model SJ-103 is supplied sterile to ensure safety for surgical implantation. Since it is a single-use, implantable device, it must be handled in a sterile environment by trained medical personnel. Additionally, the device is not MRI-compatible, so patients should avoid MRI scans after implantation.

• What regulatory pathway does this device follow, and which committee reviewed its submission?

  The CCS Model SJ-103 was cleared through the FDA’s 510(k) process under Traditional Review, classified as a Class III medical device (regulation number 870.3680). Its submission was reviewed by the Cardiovascular (CV) Advisory Committee, reflecting its role in treating cardiac rhythm disorders.