Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


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