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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(R) AND CAPSURE(R) SP SILICONE PACING LEADS
Classification Namepermanent pacemaker electrode
Generic Nameelectrode, pacemaker, permanent
Regulation Number870.3680
ApplicantMEDTRONIC VASCULAR
PMA NumberP850089
Supplement NumberS036
Date Received11/20/1996
Decision Date02/04/1997
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason labeling change - other
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for distribution by viatron, inc. Of the models capsure(r) z, 5033, 5934, 5534 and capsurefix(r) 4068 under a new trade name. The devices will be marketed under the trade names vitatron(r) impulse(tm) img 49, impulse(tm) img 49b, impulse(tm) img 49jb, and pirouet(tm)+imu 49b. And are indicated for chronic pacing and sensing of the atrium and/or ventricle.
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