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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 9790/9790C PROGRAMMER
Classification Nameimplantable pacemaker pulse-generator
Generic Namepulse generator
Regulation Number870.3610
ApplicantMEDTRONIC VASCULAR
PMA NumberP890003
Supplement NumberS061
Date Received08/02/2000
Decision Date10/02/2000
Product Code
DXY[ Registered Establishments with DXY ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - instructions
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for modification of labeling regarding the vga video output port on the model 9790/9790c series programmers, which instructs users to contact medtronic technical services for guidance in using the port.
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