Permanent Pacemaker Electrode

Basic Information

• Device Name: Permanent Pacemaker Electrode
• Trade Name: CAPSURE(R) AND CAPSURE(R)SP LEADS
• PMA Number: P850089
• Supplement Number: S032
• 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: October 31, 1995
• Date Received: January 30, 1995
• Supplement Type: Normal 180 Day Track
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review: N

Advisory Committee Statement

APPROVAL FOR A CHANGE IN THE STERILIZATION PROCESS FROM HTE USE OF 12 PERCENT ETHYLENE OXIDE (ET0), 88 PERCENT CFC, TO 100 PERCENT ET0

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