Basic Information

• Trade Name: MEDTRONIC SIGMA SERIES PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM
• PMA Number: P980035
• Supplement Number: S008
• Advisory Committee: Cardiovascular
• Decision: Approved
• Decision Code: APPR
• Decision Date: October 10, 2000
• Date Received: September 14, 2000
• Supplement Type: Real-Time Process
• Supplement Reason: Process Change - Manufacturer/Sterilizer/Packager/Supplier
• Expedited Review: N

Advisory Committee Statement

APPROVAL FOR MODIFICATIONS TO THE SIGMA AND 350 PACING SYSTEMS, SPECIFICALLY: MODIFY THE BOTTOM OF THE CONNECTOR BY ADDING A 0.020 RECESS ON THE UNDERSIDE AREA BETWEEN THE CONNECTOR AND THE CAN; CHANGE INTERCONNECT RIBBON MATERIAL; MODIFY CONNECTOR ICR AREA BY ADDING WALLS BETWEEN INTERCONNECT RIBBONS; MODIFY ICR WELD CONFIGURATION; CHANGE MATERIAL FOR SET SCREW BLOCKS; MODIFY 3.2MM CONNECTOR BORES; INCREASE POLYURETHANE THICK NESS ON OUTSIDE OF CONNECTOR IN ULTRASONIC WELD ZONES; PREFORMED ICRS; MINIMUM ADHESIVE FILL LINE ADDED AROUND THE PERIMETER OF THE FILL AREA

Applicant

• Name: MEDTRONIC Inc.
• Address: 8200 CORAL SEA STREET NE, MS MV S11, MOUNDS VIEW, MN, 55112