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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 SMART STEROID-ELUTING DUAL-COIL ICD LEADS
Generic NameImplantable cardioverter defibrillator (non-CRT)
ApplicantBIOTRONIK, INC.
6024 Jean Road
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS038
Date Received08/19/2009
Decision Date09/17/2010
Product Code LWS 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR LINOX SMART STEROID-ELUTING DUAL COIL ICD LEADS WITH SILGLIDE COATING.
Approval OrderApproval Order
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