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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameOVATIO CRT SYSTEM
Classification Namedefibrillator, automatic implantable cardioverter, with cardiac resynchronization (crt-d)
ApplicantSORIN GROUP CRM USA, INC
PMA NumberP060027
Date Received10/03/2006
Decision Date05/15/2008
Product Code
NIK[ Registered Establishments with NIK ]
Docket Number 08M-0426
Notice Date 07/28/2008
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product Yes
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Recalls CDRH 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 Order Approval Order
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 
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