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Device | LINOX(SMART) S DX STEROID-ELUTING SINGLE-COIL ICD LEADS |
Generic Name | Permanent defibrillator electrodes |
Applicant | BIOTRONIK, INC. 6024 Jean Road Lake Oswego, OR 97035 |
PMA Number | P980023 |
Supplement Number | S049 |
Date Received | 11/14/2012 |
Decision Date | 02/13/2013 |
Product Code |
NVY |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | Yes |
Review Memo | Review 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 Order | Approval Order |