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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/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original PMA or panel track supplement and may not represent the most recent labeling.
 
DeviceOVATIO CRT SYSTEM
Generic NameDefibrillator, automatic implantable cardioverter, with cardiac resynchronization (CRT-D)
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP060027
Date Received10/02/2006
Decision Date05/15/2008
Product Code NIK 
Docket Number 08M-0426
Notice Date 07/28/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE OVATIO CRT-D SYSTEM. THE OVATIO CRT-D IS INDICATED FOR VENTRICULAR ANTITACHYCARDIA PACING AND VENTRICULAR DEFIBRILLATION FOR AUTOMATED TREATMENT OF LIFE THREATENING ARRHYTHMIAS. THE DEVICE IS ALSO INDICATED FOR THE REDUCTION OF HEART FAILURE SYMPTOMS IN MEDICALLY OPTIMIZED NYHA FUNCTIONAL CLASS III AND IV PATIENTS WITH LEFT VENTRICULAR EJECTION FRACTION OF 35% OR LESS, AND A QRS DURATION OF 150 MS OR LONGER. SITUS OTW LV LEAD IS DESIGNED TO PACE THE LEFT VENTRICLE THROUGH A CORONARY VEIN. IT IS INTENDED TO BE USED IN CONJUNCTION WITH ELA MEDICAL CARDIAC SYNCHRONIZATION THERAPY PULSE GENERATORS.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S031 S032  S043 S044 S045 S040 S041 S034 S035 S064 S065 
S053 S079 S080 S068 S017 S009 S003 S004 S005 S001 S002 S027 
S081 S082 S083 S088 S030 S038 S039 S046 S050 S054 S055 S069 
S070 S076 S077 S078 S066 S067 S033 S072 S073 S074 S075 S058 
S059 S060 S056 S057 S071 S036 S037 S047 S048 S049 S061 S062 
S063 S029 S010 S015 S019 S020 S021 S028 S006 S007 S008 S011 
S012 S022 S013 S014 S023 S024 S025 S026 S016 S091 S089 S084 
S085 S086 S087 S090 S051 S094 S102 S097 S098 S096 S095 S092 
S093 S099 S100 S104 S105 S103 S101 
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