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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.
 
Trade NameCAPSURE SP NOVUS
Classification Namepermanent pacemaker electrode
Generic Nameelectrode, pacemaker, permanent
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
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 - minor
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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