Premarket Approval (PMA)

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.

• Device: MEDTRONIC CONCERTO MODEL C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CONCERTO VIRTUOSO V1.0 SOFTWARE APPLICATION
• Generic Name: Defibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
• Applicant: MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT; 8200 CORAL SEA STREET N.E.; MOUNDS VIEW, MN 55112
• PMA Number: P010031
• Supplement Number: S031
• Date Received: 11/21/2005
• Decision Date: 05/12/2006
• 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 CONCERTO MODEL C154DWK IMPLANTABLE CARDIOVERTER DEFIBRILLATOR AND CONCERTO-VIRTUOSO V1.0 SOFTWARE APPLICATION MODEL SW002. THE CONCERTO MODEL C154DWK 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 AND HAVE A LEFT VENTRICULAR EJECTION FRACTION <=35% AND A PROLONGED QRS DURATION.