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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 NameDEXTRUS STEROID-ELUTING ACTIVE FIXATION ENDOCARDIAL PACING LEADS MODELS 4135,4136 & 4137
Classification Namepulse generator, permanent, implantable
Generic Nameimplantable pacemaker pulse generator,pacemaker programmer
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Supplement NumberS048
Date Received12/13/2006
Decision Date03/08/2007
Product Code
NVZ[ Registered Establishments with NVZ ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason design change - minor
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Approval for an additional trade name for the market approved setrox s lead, as well as minor changes to the accessories, packaging, and labeling. The device, as modified, will be marketed under the trade name dextrus, and labeled for distribution by guidant. The dextrus lead is indicated for permanent pacing and sensing in either the right atrium or right ventricle in conjunction with implantable pulse generators with is-1 headers.
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