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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(R) CAPSURE(R) NOVUS STEROID ELUTING, BIPOLAR, TRANSVENOUS PACING LEAD MODELS 5054 AND 5554
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP850089
Supplement NumberS045
Date Received12/07/2000
Decision Date01/08/2001
Product Code DTB 
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 TO DISTRIBUTE THE MEDTRONIC(R) CAPSURE(R) Z NOVUS MODELS 5054 AND 5554 PACING LEADS UNDER A NEW TRADE NAME. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAME VITATRON IMPLUSE II MODELS IHP 09B AND IHP 09JB AND ARE INDICATED FOR PROVIDING PERMANENT PACING AND SENSING OF THE VENTRICLE (MODEL IHP 09B) AND ATRIUM (MODEL IHP 09JB) WHEN USED WITH A COMPATIBLE PULSE GENERATOR.
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