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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: S068 S050  S064 S065 S066 S029 S030 S031 S032 S038 S039 
S079 S080 S057 S043 S044 S045 S017 S019 S020 S003 S013 S014 
S009 S010 S011 S012 S023 S024 S025 S026 S081 S082 S083 S088 
S033 S034 S035 S053 S054 S055 S056 S058 S059 S060 S069 S070 
S076 S077 S078 S046 S047 S048 S072 S073 S074 S075 S067 S040 
S041 S036 S037 S071 S061 S062 S063 S049 S051 S004 S005 S015 
S027 S028 S021 S022 S006 S001 S002 S016 S091 S089 S084 S085 
S086 S087 S007 S008 S090 S094 S099 S100 S102 S104 S096 S092 
S093 S095 S105 S098 S101 S097 S103 
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