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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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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.
 
DeviceCONCERTO/CONCERTO II; CONSULTA; MAXIMO II; AND PROTECTA/PROTECTA XT
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP010031
Supplement NumberS232
Date Received01/24/2011
Decision Date04/04/2012
Product Code NIK 
Docket Number 12M-0814
Notice Date 07/31/2012
Advisory Committee Cardiovascular
Clinical TrialsNCT00251251
Supplement TypePanel Track
Supplement Reason Labeling Change - Indications/instructions/shelf life/tradename
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL FOR A MODIFICATION TO THE INDICATIONS FOR USE AS FOLLOWS.FOR THE CONCERTO CRT-D MODEL C154DWK, CONSULTA CRT-D MODEL D224TRK, CONCERTO II CRT-D MODEL D274TRK, PROTECTA CRT-D MODEL D334TRG, PROTECTA CRT-D MODEL D334TRM, PROTECTA XT CRT-D MODEL D314TRG, PROTECTA XT CRT-D MODEL D314TRM, AND CONSULTA CRT-D MODEL D204TRM CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) THE INDICATIONS FOR USE ARE: THE CRT-D SYSTEM IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING VENTRICULAR ARRHYTHMIASAND FOR PROVIDING CARDIAC RESYNCHRONIZATION THERAPY IN HEART FAILURE PATIENTS WHO REMAIN SYMPTOMATIC DESPITE OPTIMAL MEDICAL THERAPY, AND MEET ANY OF THE FOLLOWING CLASSIFICATIONS: 1) NEW YORK HEART ASSOCIATION (NYHA) FUNCTIONAL CLASS III OR IV AND WHO HAVE A LEFT VENTRICULAR EJECTION FRACTION <= 35% AND A PROLONGED QRS DURATION. 2) LEFT BUNDLE BRANCH BLOCK (LBBB) WITH A QRS DURATION >= 130 MS, LEFT VENTRICULAR EJECTIONFRACTION <= 30%, AND NYHA FUNCTIONAL CLASS II. THE SYSTEM IS ALSO INDICATED FOR USE IN PATIENTS WITH ATRIAL TACHYARRHYTHMIAS, OR THOSE PATIENTS WHO ARE AT SIGNIFICANT RISK FOR DEVELOPING ATRIAL TACHYARRHYTHMIAS. ATRIAL RHYTHM MANAGEMENT FEATURES SUCH AS ATRIAL RATE STABILIZATION (ARS), ATRIAL PREFERENCE PACING (APP), AND POST MODE SWITCH OVERDRIVE (PMOP) ARE INDICATED FOR THE SUPPRESSION OF ATRIAL TACHYARRHYTHMIAS IN IMPLANTABLE CARDIOVERTER DEFIBRILLATOR (ICD)-INDICATED PATIENTS WITH ATRIAL SEPTAL LEAD PLACEMENT AND AN ICD INDICATION. FOR THE MAXIMO II CRT-D MODEL D284TRK AND MAXIMO IICRT-D MODEL D264TRM CARDIAC RESYNCHRONIZATION THERAPY DEFIBRILLATORS (CRT-DS) THE INDICATIONS FOR USE ARE: (FOR ADDITIONAL INFORMATION, PLEASE SEE APPROVAL ORDER.)
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
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