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. |
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Device | CONTAK RENEWAL CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) |
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 | S002 |
Date Received | 06/07/2002 |
Decision Date | 12/20/2002 |
Product Code |
NIK |
Advisory Committee |
Cardiovascular |
Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
Recalls | CDRH Recalls |
Approval Order Statement APPROVAL FOR THE COMMERCIAL INTRODUCTION OF THE CONTAK RENEWAL MODEL H135 CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) AND THE MODEL 2845 VERSION 1.7 SOFTWARE. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME CONTAK RENEWAL AND IS INDICATED AS FOLLOWS: THE CONTAK RENEWAL HEART FAILURE DEVICE SYSTEM IS INDICATED FOR USE IN THE FOLLOWING: PATIENTS WHO ARE AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS AND WHO HAVE MODERATE TO SEVERE HEART FAILURE (NYHA CLASS III/IV) INCLUDING LEFT VENTRICULAR DYSFUNCTION (EF <35%) AND QRS DURING >120 MS AND REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL HEART FAILURE DRUG THERAPY. PATIENT POPULATIONS AT HIGH RISK OF SUDDEN CARDIAC DEATH DUE TO VENTRICULAR ARRHYTHMIAS INCLUDE, BUT ARE NOT LIMITED TO, THOSE WITH: 1) SURVIVAL OF AT LEAST ONE EPISODE OF CARDIAC ARREST (MANIFESTED BY THE LOSS OF CONSCIOUSNESS) DUE TO A VENTRICULAR TACHYARRHYTHMIA. 2) RECURRENT, POORLY TOLERATED SUSTAINED VENTRICULAR TACHYCARDIA (VT). NOTE: THE CLINICAL OUTCOME OF HEMODYNAMICALLY STABLE, SUSTAINED-VT PATIENTS IS NOT FULLY KNOWN. SAFETY AND EFFECTIVENESS STUDIES HAVE NOT BEEN CONDUCTED. 3) PRIOR MYOCARDIAL INFARCTION, LEFT VENTRICULAR EJECTION FRACTION OF <35%, AND A DOCUMENTED EPISODE OF NONSUSTAINED VT, WITH AN INDUCIBLE VENTRICULAR TACHYARRHYTHMIA. 4) PATIENTS SUPPRESSIBLE WITH IV PROCAINAMIDE OR AN EQUIVALENT ANTIARRHYTHMIC (DRUG) HAVE NOT BEEN STUDIED. |
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