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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 NameLINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS
Classification Namepermanent defibrillator electrodes
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS049
Date Received11/15/2012
Decision Date02/13/2013
Product Code
NVY[ Registered Establishments with NVY ]
Advisory Committee Cardiovascular
Supplement Typenormal 180 day track
Supplement Reason change design/components/specifications - other
Expedited Review Granted? No
Combination Product Yes
Review Memo Review Memo
Approval Order Statement 
Approval for the addition of a new model to the linox smart icd lead family. This new model will be marketed under the trade name linox smart s dx icd lead and indicated for use in the right ventricle of patients for whom implantable cardioverter defibrillators are indicated; it can only be used with the lumax vr-t dx icd as a system. The lead incorporates two atrial sensing rings that replace the svc coil; in addition, an is-1 connector was added for the atrial sensing rings and the df-1 connector for the svc coil was removed.
Approval Order Approval Order
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