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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 & LINOX(SMART) T STEROID-ELUTING DUAL-COIL ICD LEADS
Classification Nameimplantable cardioverter defibrillator (non-crt)
Generic Nameimplantable cardioverter defibrillator
ApplicantBIOTRONIK, INC.
PMA NumberP980023
Supplement NumberS043
Date Received12/29/2010
Decision Date02/28/2011
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: 1) addition of silglide surface treatment of the silicone lead body; 2) increase in outer diameter of lead body at df-1 connector exit; and 3) additional suppliers for silicone and conductor materials.
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