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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(R) CAPSURE(R) EPI PACING LEAD MODEL 4695
Classification Namepermanent pacemaker electrode
Generic Namecapsure epi epicardial steroid eluting pacing lead
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP950024
Supplement NumberS002
Date Received07/01/1998
Decision Date09/16/1999
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 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.
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