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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 TD IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS023
Date Received06/05/2006
Decision Date07/11/2006
Product Code
LWS[ Registered Establishments with LWS ]
Advisory Committee Cardiovascular
Supplement Typereal-time process
Supplement Reason change design/components/specifications - component
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
Approval for a lead based on the kentrox sl and linox sd icd leads with 0. 11 mm filaments in the lead tip conductor. The device, as modified, will be marketed under the trade name linox td implantable cardioverter defibrillator lead and is 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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