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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.
Classification Namepermanent pacemaker electrode
Generic Nameelectrode, pacemaker, permanent
Regulation Number870.3680
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.