Unilith Pulse Generator VVI #7542

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

510(k) Number

K830401 ↗

FDA Product Code

DXY

Device Class

Class III

Regulation

21 CFR Part 870.3610

Advisory Committee

Cardiovascular

FDA Decision

SESE Substantially Equivalent

• Pacing Lead #PMA F 860

  Class III

  FDA 510(k) K830457 Active Cleared 17 Mar 1983

• Opus Pulse Generators Models 2001, 2003, and 2004

  Class III

  FDA 510(k) K882474 Active Cleared 12 Sep 1988

• Lead Models MUM 1260, MUM 1290

  Class III

  FDA 510(k) K790386 Active Cleared 3 Apr 1979

• Focus J81F, J83F, J41F, J43F Pacing Leads

  Class III

  FDA 510(k) K896742 Active Cleared 17 Jul 1990

• Focus T41, T41F, T43, T43F, T44F

  Class III

  FDA 510(k) K904255 Active Cleared 18 Jan 1991

• Opus Pacemakers (Models 4001, 4003, 4004, 4023, 4024)

  Class III

  FDA 510(k) K952364 Active Cleared 1 Sep 1995

See all devices from Ela Medical, Inc. →

• What is the primary purpose of the Unilith Pulse Generator VVI #7542 and how does it function in the body?

  The Unilith Pulse Generator VVI #7542 is designed as an implantable pacemaker to manage bradycardia or conduction disorders by delivering ventricular demand pacing. It monitors the heart’s natural rhythm and provides electrical impulses to the heart muscle only when the spontaneous heartbeat falls below a preset rate, ensuring consistent cardiac output.

• Is this device intended for reuse, or is it meant to be used only once after implantation?

  The Unilith Pulse Generator VVI #7542 is supplied as a sterile, single-use component. While it is intended for surgical implantation, it is not designed for reuse, and proper handling and storage are required to maintain its integrity before and after use.

• What storage conditions should be followed to ensure the device remains effective before implantation?

  Since the Unilith Pulse Generator VVI #7542 is sterile and single-use, it must be stored in a way that preserves its sterility and structural integrity. The manufacturer’s guidelines (not detailed here) should be followed, but generally, this includes keeping it in its original packaging, away from extreme temperatures, moisture, and physical damage until ready for use.

• What regulatory pathway was followed for FDA clearance of this device, and how does that affect its use?

  The Unilith Pulse Generator VVI #7542 received FDA clearance through a 510(k) submission (K830401), classified as substantially equivalent to a predicate device under 21 CFR 870.3610. This means it was reviewed by the FDA’s Cardiovascular (CV) advisory committee and determined to meet safety and effectiveness standards for implantable pacemaker pulse-generators, ensuring it adheres to established regulatory requirements for use in clinical settings.