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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 NameMEDTRONIC CAPSURE SP NOVUS MODELS 4092 AND 4592 AND VITATRON EXCELLENCE PS & MODELS IMK49B AND IMK 49JB
Classification Namepermanent pacemaker electrode
Generic Nameelectrode, pacemaker, permanent
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP830061
Supplement NumberS027
Date Received03/02/1998
Decision Date08/27/1998
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for new pacing leads models. The devices, as modified, will be marketed under the trade names capsure(r) sp novus models 4092 and 4592 and vitatron excellence ps+ models imk49b and imk49jb and are indicated for permanent pacing and sensing of the strium or ventricle.
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