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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) EPI PACING LEAD MODEL 4695
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantMedtronic, Inc.
8200 Coral Sea St. N.E
Ms Mvs11
Mounds View, MN 55112
PMA NumberP950024
Supplement NumberS002
Date Received07/01/1998
Decision Date09/16/1999
Product Code DTB 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for a new pacing lead model and is indicated for use with a pulse generator as part of a cardiac pacing system. The lead has application where implantable epicardial atrial or ventricular, single or dual chamber pacing systems are indicated.
Post-Approval StudyShow Report Schedule and Study Progress
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