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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.
Classification Nameimplantable pulse generator, pacemaker (non-crt)
Generic Nameimplantable pulse generator, pacemaker (non-crt)
Medtronic, Inc
8200 coral sea street ne
mounds view, MN 55112
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
Approval Order Statement 
Approval for the revo mrisurescan 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 thefollowing:1) rate adaptive pacing in patients who may benefit from increased pacing ralesconcurrent 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; andd) bradycardia-tachycardia syndrome to prevent symptomatic bradycardia or someforms of symptomatic tachyarrhythmias. (see approval order for add'l detail).
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S010 
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S051 S053 S054 S055 S056 S057 S058 S059 S060 
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S099 S100 S102 S103 S104 S105 S106 S107 S108 
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S118 S119 S120 S121 S123 S124 S125 S126 S127 
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S137 S138 S139 S140 S141 S142 S143 S144 S145 
S146 S147 S148 S149 S150 S151 S152 S153 S154 
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