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Device | CONTAK RENEWAL 3 AVT CRT-D SYSTEM |
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 | S037 |
Date Received | 11/10/2004 |
Decision Date | 03/13/2008 |
Product Code |
NIK |
Docket Number | 08M-0243 |
Notice Date | 04/24/2008 |
Advisory Committee |
Cardiovascular |
Supplement Type | Panel Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Approval Order Statement APPROVAL FOR THE CONTAK RENEWAL 3 AVT AND CONTAK RENEWAL 3 AVT HE SYSTEMS. THE SYSTEMS ARE INDICATED FOR THE FOLLOWING: CONTAK RENEWAL 3 AVT CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) ARE INDICATED FOR PATIENTS WITH MODERATE TO SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR DYSFUNCTION (EF <= 35%) AND QRS DURATION >= 120 MS. CONTAK RENEWAL 3 AVT PROVIDES ATRIAL ANTITACHYCARDIA PACING AND ATRIAL DEFIBRILLATION TREATMENT FOR PATIENTS WITH A HISTORY OF OR WHO ARE AT RISK OF DEVELOPING ATRIAL ARRHYTHMIAS. |
Approval Order | Approval Order |
Summary | Summary of Safety and Effectiveness |
Labeling | Labeling
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