Permanent Pacemaker Electrode

Basic Information

• Device Name: Permanent Pacemaker Electrode
• Trade Name: MEDTRONIC PACING LEADS
• PMA Number: P830061
• 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: 30-Day Notice Accepted
• Decision Code: OK30
• Decision Date: August 8, 2001
• Date Received: July 17, 2001
• Supplement Type: 30-Day Notice
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review: N

Advisory Committee Statement

CHANGE IN THE SUPPLIER OF POLYETHERURETHANE.

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