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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) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS
Generic NamePermanent defibrillator electrodes
ApplicantBiotronik, Inc.
6024 Jean Rd.
Lake Oswego, OR 97035
PMA NumberP980023
Supplement NumberS049
Date Received11/14/2012
Decision Date02/13/2013
Product Code NVY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductYes
Predetermined Change Control Plan AuthorizedNo
Review MemoReview Memo
Approval Order Statement  
APPROVAL FOR THE ADDITION OF A NEW MODEL TO THE LINOX SMART ICD LEAD FAMILY. THIS NEW MODEL WILL BE MARKETED UNDER THE TRADE NAME LINOX SMART S DX ICD LEAD AND INDICATED FOR USE IN THE RIGHT VENTRICLE OF PATIENTS FOR WHOM IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AREINDICATED; IT CAN ONLY BE USED WITH THE LUMAX VR-T DX ICD AS A SYSTEM. THE LEAD INCORPORATES TWO ATRIAL SENSING RINGS THAT REPLACE THE SVC COIL; IN ADDITION, AN IS-1 CONNECTOR WAS ADDED FOR THE ATRIAL SENSING RINGS AND THE DF-1 CONNECTOR FOR THE SVC COIL WAS REMOVED.
Approval OrderApproval Order
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