MEDTRONIC(R) TRANSVENE LEAD SYSTEM

P920015 · Medtronic, Inc. · NVY · Dec 9, 1993 · Cardiovascular

Device Facts

• Record ID: P920015
• Device Name: MEDTRONIC(R) TRANSVENE LEAD SYSTEM
• Applicant: Medtronic, Inc.
• Product Code: NVY · Cardiovascular
• Decision Date: Dec 9, 1993
• Decision: APPR
• Device Class: Class 3
• Attributes: Expedited Review

Regulatory Classification

Identification

Permanent defibrillator electrodes are used with compatible implantable cardioverter defibrillators (ICD) and cardiac rhythm therapy-defibrillators (CRT-D) to sense the cardiac rhythm and to deliver high energy therapy to the heart when tachycardia is detected. Some transvenous models can also be used for pacing the right ventricle.