OVATIO CRT SYSTEM

Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)

FDA Premarket Approval P060027

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.

Pre-market Approval Supplement Details

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.

DeviceOVATIO CRT SYSTEM
Classification NameDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
Generic NameDefibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d)
ApplicantMicroPort CRM USA Inc.
Date Received2006-10-02
Decision Date2008-05-15
Notice Date2008-07-28
PMAP060027
SupplementS
Product CodeNIK
Docket Number08M-0426
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product Yes
Applicant Address MicroPort CRM USA Inc. 5640 Airline Road arlington, TN 38002
Summary:Summary of Safety and Effectiveness
Labeling: Labeling
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P060027Original Filing
S105 2020-09-30 Normal 180 Day Track
S104 2020-09-24 30-day Notice
S103 2020-07-13 30-day Notice
S102 2020-02-10 30-day Notice
S101
S100 2019-11-15 30-day Notice
S099 2019-02-05 30-day Notice
S098 2018-12-20 Real-time Process
S097 2018-11-13 30-day Notice
S096 2018-04-19 30-day Notice
S095 2018-03-29 30-day Notice
S094 2018-02-26 30-day Notice
S093 2018-01-03 Real-time Process
S092 2018-01-03 30-day Notice
S091 2017-07-07 30-day Notice
S090 2017-05-22 Real-time Process
S089 2017-02-21 30-day Notice
S088 2016-12-19 Normal 180 Day Track
S087 2016-08-23 30-day Notice
S086 2016-08-23 30-day Notice
S085 2016-08-23 30-day Notice
S084 2016-08-09 Real-time Process
S083 2016-07-21 Real-time Process
S082 2016-07-14 30-day Notice
S081 2016-07-13 30-day Notice
S080 2015-11-17 135 Review Track For 30-day Notice
S079 2015-10-20 Normal 180 Day Track
S078 2015-07-07 30-day Notice
S077 2015-07-02 30-day Notice
S076 2015-07-01 30-day Notice
S075 2015-02-24 30-day Notice
S074 2015-02-19 30-day Notice
S073 2015-02-18 30-day Notice
S072 2015-02-11 Normal 180 Day Track
S071 2014-11-21 30-day Notice
S070 2014-10-01 Normal 180 Day Track No User Fee
S069 2014-09-15 Real-time Process
S068 2014-08-06 30-day Notice
S067 2014-06-20 30-day Notice
S066 2014-05-15 Normal 180 Day Track
S065 2014-04-24 Real-time Process
S064 2014-04-23 Real-time Process
S063 2014-04-10 30-day Notice
S062 2014-03-24 30-day Notice
S061 2014-03-18 Real-time Process
S060 2014-02-12 Real-time Process
S059 2014-01-29 30-day Notice
S058 2014-01-29 30-day Notice
S057 2013-10-31 30-day Notice
S056 2013-10-17 30-day Notice
S055 2013-09-11 30-day Notice
S054 2013-09-11 30-day Notice
S053 2013-08-21 Normal 180 Day Track
S052
S051 2013-07-15 30-day Notice
S050 2013-04-10 30-day Notice
S049 2013-02-25 30-day Notice
S048 2013-02-15 Real-time Process
S047 2013-02-11 30-day Notice
S046 2012-12-21 30-day Notice
S045 2012-07-31 30-day Notice
S044 2012-07-06 30-day Notice
S043 2012-07-05 30-day Notice
S042
S041 2012-05-16 30-day Notice
S040 2012-05-16 30-day Notice
S039 2012-03-23 30-day Notice
S038 2012-03-13 Normal 180 Day Track
S037 2012-01-27 30-day Notice
S036 2012-01-05 30-day Notice
S035 2011-12-12 30-day Notice
S034 2011-11-10 30-day Notice
S033 2011-10-31 30-day Notice
S032 2011-09-01 Normal 180 Day Track
S031 2011-06-06 30-day Notice
S030 2011-02-28 30-day Notice
S029 2010-12-16 Real-time Process
S028 2010-08-12 Real-time Process
S027 2010-07-16 Normal 180 Day Track No User Fee
S026 2010-06-28 Normal 180 Day Track
S025 2010-06-04 30-day Notice
S024 2010-05-17 Real-time Process
S023 2010-04-26 30-day Notice
S022 2010-03-30 30-day Notice
S021 2010-02-12 30-day Notice
S020 2010-02-05 30-day Notice
S019 2010-02-04 135 Review Track For 30-day Notice
S018
S017 2010-01-06 30-day Notice
S016 2009-11-16 30-day Notice
S015 2009-09-24 Normal 180 Day Track
S014 2009-04-09 30-day Notice
S013 2009-03-31 30-day Notice
S012 2009-03-04 30-day Notice
S011 2009-02-20 30-day Notice
S010 2009-01-28 30-day Notice
S009 2008-12-17 Normal 180 Day Track No User Fee
S008 2008-11-12 Real-time Process
S007 2008-11-10 135 Review Track For 30-day Notice
S006 2008-09-15 30-day Notice
S005 2008-08-21 Real-time Process
S004 2008-08-13 Normal 180 Day Track
S003 2008-06-23 Special (immediate Track)
S002 2008-06-13 Normal 180 Day Track No User Fee
S001 2008-06-10 Real-time Process

NIH GUDID Devices

Device IDPMASupp
08031527012278 P060027 032
08031527012810 P060027 066
08031527015538 P060027 079
08031527015484 P060027 079
08031527015569 P060027 088

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