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Device | EASYTRAK LEAD MODELS IS-1 4535/4536/4537/4538 CORONARY VENOUS STEROID-ELUTING SINGLE-ELECTRODE PACE/SENSE LEAD |
Generic Name | Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S010 |
Date Received | 03/12/2003 |
Decision Date | 06/13/2003 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Real-Time Process |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR CHANGE FROM A LV-1 LEAD CONNECTOR TO AN IS-1 LEAD CONNECTOR DESIGN. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME EASYTRAK IS-1 LEAD, AND IS INDICATED FOR CHRONIC LEFT VENTRICULAR PACING AND SENSING VIA THE CORONARY VEINS WHEN USED IN CONJUNCTION WITH A COMPATIBLE CARDIAC RESYNCHRONIZATION THERAPY (CRT) DEVICE. |