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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 PACING SYSTEM AND MEDTRONIC 350 SERIES PACING SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pulse generator programming software
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS029
Date Received05/12/2003
Decision Date06/06/2003
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Recalls CDRH Recalls
Approval Order Statement 
Approval for modifications to the connector in the sigma and 350 series pacemakers to improve yield and manufacturability.
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