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 | COGNIS CRT-D |
Generic Name | Implantable pulse generator, pacemaker (non-CRT) |
Applicant | Boston Scientific Corp. 4100 HAMLINE AVE NORTH ST. PAUL, MN 55112 |
PMA Number | P010012 |
Supplement Number | S165 |
Date Received | 12/07/2007 |
Decision Date | 05/08/2008 |
Product Code |
LWP |
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 TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL 2868, REV. 1.01 AND THE MODEL 6628 TORQUE WRENCH. THE DEVICE, AS MODIFIED, WILL BE MARKETED UNDER THE TRADE NAME TELIGEN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR MODELS E102 AND E110, THE COGNIS CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATOR (CRT-D) MODELS N118 AND N119, APPLICATION SOFTWARE MODEL 2868, REV. 1.01 AND THE MODEL 6628 TORQUE WRENCH. THE COGNIS CRT-D DEVICES ARE INDICATED FOR PATIENTS WITH MODERATE-TO-SEVERE HEART FAILURE (NYHA III/IV) WHO REMAIN SYMPTOMATIC DESPITE STABLE, OPTIMAL FAILURE DRUG THERAPY, AND HAVE LEFT VENTRICULAR (LV) DYSFUNCTION (EJECTION FRACTION <=35%) AND QRS DURATION >=120 MS. THE TELIGEN DEVICES ARE INTENDED TO PROVIDE VENTRICULAR ANTITACHYCARDIA PACING (ATP) AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE-THREATENING VENTRICULAR ARRHYTHMIAS. |
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