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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 Yes
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 S086 
S087 S088 S089 S090 S092 S095 
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