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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 350 SERIES PACING SYSTEM
Generic Nameimplantable pulse generator programming software
ApplicantMEDTRONIC VASCULAR
PMA NumberP980035
Supplement NumberS004
Date Received11/11/1999
Decision Date12/09/1999
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for the medtronic model 350 series pacing system programmed by the medtronic model 9790/c programmer with sigma model 9963/9963a software.
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