Cordis Sequicor Theta Models 233D & 233E

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

Generic Name

Implantable pulse generator, pacemaker (non-CRT)

PMA Number

P820014 ↗

FDA Product Code

LWP

Device Class

Class III

Advisory Committee

Cardiovascular

FDA Decision

APPR Approved

PMA Supplement

S017

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• Bifurcated Vs-1 to Vs-1 Lead Adaptor

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  Class III

  FDA 510(k) K901402 Active Cleared 12 Jun 1990

See all devices from Telectronics Pacing Systems, Inc. →

• Are the Cordis Sequicor Theta Models 233D & 233E designed for patients requiring cardiac resynchronization therapy (CRT)?

  No, these devices are explicitly classified as non-CRT pacemakers. They are intended to regulate heart rhythm by delivering electrical impulses to the heart muscle when abnormal electrical activity is detected, but they are not designed for biventricular pacing or cardiac resynchronization therapy.

• How are the Cordis Sequicor Theta Models 233D & 233E supplied, and are they reusable?

  The devices are supplied sterile and are intended for single-use only. They are not designed for reuse, which is consistent with their classification as implantable pulse generators requiring surgical implantation.

• What regulatory pathway was followed for the approval of these devices, and what is the associated PMA number?

  The Cordis Sequicor Theta Models 233D & 233E were approved through the FDA’s Premarket Approval (PMA) process, which is required for Class III devices like implantable pulse generators. The primary PMA number is P820014, with a supplement noted as S024.

• Are there different models available within the Cordis Sequicor Theta series, and if so, how do they differ?

  Yes, the series includes Models 233D and 233E, though the provided data does not specify technical differences between them. Both are classified under the same generic name (Implantable Pulse Generator, Pacemaker) and product code (LWP), so distinctions would require additional manufacturer documentation.

• What is the intended clinical setting for use of the Cordis Sequicor Theta Models 233D & 233E?

  These devices are intended for use in clinical settings requiring cardiac rhythm management, specifically for surgical implantation to regulate heart rhythm in patients with abnormal electrical activity. They are not intended for home use or non-surgical applications.