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U.S. Department of Health and Human Services

Premarket Approval (PMA)

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Note: this medical device has supplements. The device description may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameCONCERTO/INSYNC SENTRY/INSYNC MAXIMO IMPLANTABLE CARDIOVASCULAR DEFIBRILLATORS WITH CARDIAC RESYNCHICNIZATION
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
PMA NumberP010031
Date Received05/04/2001
Decision Date06/26/2002
Product Code
NIK[ Registered Establishments with NIK ]
Docket Number 02M-0381
Notice Date 08/26/2002
Advisory Committee Cardiovascular
Expedited Review Granted? Yes
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the insync icd model 7272 dual chamber implantable cardioverter defibrillator with cardiac resynchronization therapy and the model 9969 application software. The insync icd model 7272 is indicated for ventricular antitachycardia pacing and ventricular defibrillation for automated treatment of life threatening ventricular arrhythmias. The system is also indicated for the reduction of the symptoms of moderate to severe heart failure (nyha functional class iii or iv) in those patients who remain symptomatic despite stable, optimal medical therapy (as defined in the clinical trials section), and have a left ventricular ejection fraction less than or equal to 35% and a qrs duration greater than or equal to 130 ms.
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
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