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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.
 
DeviceSELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60
Classification Namepermanent pacemaker electrode
Generic Namepermanent pacemaker electrode
Regulation Number870.3680
Applicant
BIOTRONIK, INC.
6024 jean road
lake oswego, OR 97035
PMA NumberP950037
Supplement NumberS034
Date Received07/14/2003
Decision Date03/08/2004
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 addition of a drug collar to the pacing lead. The device, as modified, will be marketed under the trade name selox sr and is indicated as following: botronik's selox sr transvenous, steroid-eluting, active fixation endocardial leads are indicated for permanent pacing and sensing. Active fixation pacing leads with a bipolar (bp) is-1 connector configuration are designed for use in conjunction with implantable pulse generators with is-1 headers. The leads may be used with single or dual chamber pacing systems. The selox sr lead models are intended for placement in either the right atrium or right ventricle.
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