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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 9790/9790C PROGRAMMER
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS061
Date Received08/02/2000
Decision Date10/02/2000
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
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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