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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 SP NOVUS
Generic Namepermanent pacemaker Electrode
Regulation Number870.3680
ApplicantMedtronic Cardiac Rhythm Disease Management
8200 Coral Sea St. N.E
Mounds View, MN 55112
PMA NumberP850089
Supplement NumberS040
Date Received10/01/1998
Decision Date10/29/1998
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
Predetermined Change Control Plan AuthorizedNo
Approval Order Statement  
Approval for distribution under a new trade name. The devices will be marketed under the trade name Vitatron(R) Excellence SS+ Models IML 49B and IML 49JB and indicated for use with pulse generators as part of a caridac pacing system to provide chronic pacing and sensing of the ventricle.
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