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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceMEDTRONIC SIGMA SERIES PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP980035
Supplement NumberS008
Date Received09/14/2000
Decision Date10/10/2000
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Process Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order 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
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