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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 supplement. The device description may have changed. Be sure to look at the original PMA to get an up-to-date view of this device.
 
DeviceCAPSURE SP NOVUS
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
Applicant
MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP850089
Supplement NumberS040
Date Received10/01/1998
Decision Date10/29/1998
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason labeling change - indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination Product No
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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