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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.
 
DeviceCAPSURE(R) AND CAPSURE(R) SP SILICONE PACING LEADS
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 NumberS036
Date Received11/20/1996
Decision Date02/04/1997
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR DISTRIBUTION BY VIATRON, INC. OF THE MODELS CAPSURE(R) Z, 5033, 5934, 5534 AND CAPSUREFIX(R) 4068 UNDER A NEW TRADE NAME. THE DEVICES WILL BE MARKETED UNDER THE TRADE NAMES VITATRON(R) IMPULSE(TM) IMG 49, IMPULSE(TM) IMG 49B, IMPULSE(TM) IMG 49JB, AND PIROUET(TM)+IMU 49B. AND ARE INDICATED FOR CHRONIC PACING AND SENSING OF THE ATRIUM AND/OR VENTRICLE.
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