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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
Trade NameMEDTRONIC SIGMA SERIES PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM
Generic Nameimplantable pulse generator programming software
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS008
Date Received09/14/2000
Decision Date10/10/2000
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason process change: manufacturing
Expedited Review Granted? No
Combination Product No
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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