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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 PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceLINOX S & LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS027
Date Received12/18/2006
Decision Date01/26/2007
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeReal-Time Process
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Approval Order Statement  
APPROVAL FOR LEADS BASED ON THE LINOX SD AND LINOX TD LEADS WITH ONE SHOCK COIL INSTEAD OF TWO SHOCK COILS. THE DEVICES, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAMES LINOX S IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEAD AND LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR LEAD AND ARE INDICATED FOR USE IN CONJUNCTION WITH A BIOTRONIK ICD. CURRENTLY, DATA IS NOT AVAILABLE REGARDING THE USE OF THESE LEAD SYSTEMS WITH ICDS OF OTHER MANUFACTURERS. USE OF OTHER ICDS MAY ADVERSELY AFFECT SENSING AND/OR THERAPY DELIVERY.
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