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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 NameREVO MRI SURESCAN IPG AND PACING SYSTEM
Classification Nameimplantable pulse generator, pacemaker (non-crt)
ApplicantMEDTRONIC, INC
PMA NumberP090013
Date Received06/09/2009
Decision Date02/08/2011
Product Code
LWP[ Registered Establishments with LWP ]
Docket Number 11M-0105
Notice Date 02/24/2011
Advisory Committee Cardiovascular
Clinical Trials NCT00433654
Expedited Review Granted? No
Combination Product No
Information About: Labeling, Approval Order, Summary of Safety and Effectiveness
Approval Order Statement 
Approval for the revo mri surescan pacing system, which consists of the medtronic revo mri¿ surescan¿ model rvdr01 ipg, the medtronic capsurefix mri¿ surescan¿ 5086mri lead, and the revo mri¿ software application model sw018. This system is indicated as follows: the medtronic revo mri¿ surescan¿ model rvdr01 ipg is indicated for use as a system consisting of a revo mri surescan ipg implanted with two capsure fix mri¿ surescan¿ 5086mri leads. A complete system is required for use in the mri environment. The medtronic revo mri¿ surescan¿ model rvdr01 ipg is indicated for the following: 1) rate adaptive pacing in patients who may benefit from increased pacing rales concurrent with increases in activity; 2) accepted patient conditions warranting chronic cardiac pacing include: a) symptomatic paroxysmal or permanent second-degree or third-degree av block; b) symptomatic bilateral bundle branch block; c) symptomatic paroxysmal or transient sinus node dysfunctions with or without associated av conduction disorders; and d) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias. (see approval order for add'l detail).
Approval Order Approval Order
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
S011 S012 S013 S015 S016 S017 S018 S019 S020 
S021 S022 S023 S024 S026 S027 S028 S029 S030 
S031 S032 S033 S034 S035 S037 S038 S039 S040 
S041 S042 S043 S044 S045 S047 S048 S049 S050 
S051 S053 S054 S055 S056 S057 S058 S059 S060 
S061 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 S095 S096 S097 S098 
S099 S100 S102 S103 S104 S105 S106 S107 S108 
S109 S110 S111 S112 S113 S114 S115 S116 S117 
S118 S119 S120 S121 S123 S124 S125 S126 S127 
S128 S129 S130 S131 S133 S134 S135 
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