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U.S. Department of Health and Human Services

Devices@FDA
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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) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP930039
Supplement NumberS002
Date Received06/24/1996
Decision Date01/02/1997
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Location Change - Manufacturer/Sterilizer/Packager/Supplier
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF MODEL 4067, 4568, 5067, 5068 AND 5568 TO THE CAPSUREFIX(R) LINE. THESE LEAD MODELS WILL ALSO BE DISTRIBUTED BY VIATRON, INC., UNDER THE TRADENAME "PIROUT" (MODELS IMU49, IMU49JB, IMX49, IMX49B AND IMU49JB).
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