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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 S & LINOX T IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD) LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS027
Date Received12/18/2006
Decision Date01/26/2007
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 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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