Permanent Pacemaker Electrode

Basic Information

• Device Name: Permanent Pacemaker Electrode
• Trade Name: CAPSURE SP NOVUS MODEL 5092 (AND VITATRON EXCELLENCE SS+ MODEL IML 49B)
• PMA Number: P850089
• Supplement Number: S042
• Device Class: FDA Class 3
• Product Code: DTB
• Generic Name: permanent pacemaker Electrode
• Regulation Number: 870.3680
• Medical Specialty: Cardiovascular
• Advisory Committee: Cardiovascular
• Decision: Approved
• Decision Code: APPR
• Decision Date: August 11, 1999
• Date Received: July 9, 1999
• Supplement Type: Real-Time Process
• Supplement Reason: Change Design/Components/Specifications/Material
• Expedited Review: N

Advisory Committee Statement

Approval for a tine design change for Model 5092 and IML 49B leads.

Classifications

This FDA Pre-Market Approval entry is associated with 1 FDA classification via its product code.

Product Code	Device Name	Device Class	Medical Specialty
DTB	Permanent Pacemaker Electrode	FDA class 3	Cardiovascular

Applicant

• Name: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
• Address: 8200 CORAL SEA STREET N.E., MOUNDS VIEW, MN, 55112