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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 NameSELOX SR STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEAD MODELS SR45, SR53, SR60 SR 53,SELOX SR 60
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS034
Date Received07/16/2003
Decision Date03/08/2004
Product Code
DXY[ Registered Establishments with DXY ]
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 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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