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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 Namepermanent pacemaker electrode
Regulation Number870.3680
8200 coral sea street n.e.
mounds view, MN 55112
PMA NumberP830061
Supplement NumberS034
Date Received03/01/2002
Decision Date07/23/2002
Product Code
DTB[ Registered Establishments with DTB ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications/material
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for pacing leads that incorporate a new surface coating, a new electrode geometry, a new combination of previously used steroids, and a new tapered stylet. The device, as modified, will be marketed under the trade names capsure sense lead models 4074/4574/4073 and the vitatron crystalline lead models icm09b, icm09jb, and icm09. These devices are indicated for pacing or sensing in the atrium or ventricle. The leads have application where implantable atrial or ventricular single-chamber or dual-chamber pacing systems are indicated.