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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/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.
Generic Nameimplantable pulse generator, pacemaker (non-crt)
4100 hamline avenue north
st paul, MN 55112
PMA NumberP150012
Date Received03/03/2015
Decision Date04/25/2016
Product Codes NVN LWP 
Docket Number 16M-1222
Notice Date 05/11/2016
Advisory Committee Cardiovascular
Clinical TrialsNCT00907361
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
Approval Order Statement  
Approval for The ImageReady MR Conditional Pacing System. The device is indicated for the treatment of the following conditions:1) Symptomatic paroxysmal or permanent second- or third-degree AV block;2) Symptomatic bilateral bundle branch block;3) Symptomatic paroxysmal or transient sinus node dysfunction with or without associated AV conduction disorders (i.e., sinus bradycardia, sinus arrest, sinoatrial [SA] block);4) Bradycardia-tachycardia syndrome, to prevent symptomatic bradycardia or some forms of symptomatic tachyarrhythmias; and5) Neurovascular (vaso-vagal) syndromes or hypersensitive carotid sinus syndromes.Adaptive-rate pacing is indicated for patients exhibiting chronotropic incompetence and who may benefit from increased pacing rates concurrent with increases in minute ventilation and/or level of physical activity.Dual-chamber and atrial tracking modes are also indicated for patients who may benefit from maintenance of AV synchrony.Dual chamber modes are specifically indicated for treatment of the following:1) Conduction disorders that require restoration of AV synchrony, including varying degrees of AV block;2) VVI intolerance (i.e., pacemaker syndrome) in the presence of persistent sinus rhythm; and3) Low cardiac output or congestive heart failure secondary to bradycardia. Passive-fixation Non-MRI Models 7631, 7632, 7635 and 7636 and MRI Models 7731, 7732, 7735 and 7736 are indicated for chronic pacing and sensing in the right atrium (Preformed Atrial J) or right ventricle (Straight) when used with a compatible pulse generator.Active-fixation Non-MRI Models 7640, 7641, and 7642 and MRI Models 7740, 7741, and 7742 are indicated for chronic pacing and sensing in the right atrium and/or right ventricle when used with a compatible pulse generator.The intended use of the slit suture sleeve accessory is to secure and immobilize Boston Scientific Ingevity leads at the venous entry site.The delivery stylet accessory is indicated for use with Boston Scientific implantable transvenous leads.
Approval OrderApproval Order
SummarySummary of Safety and Effectiveness
Labeling Part 2
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 S018 S019 S020 S021 S022 S023 
S024 S025 S026 S027 S028 S029 S030 S031 S032 S033 S034 S035 
S036 S037 S038 S039 S040 S041 S042 S043 S044 S045 S046 S047 
S048 S049 S050 S051 S052 S053 S054 S055 S056 S058 S059 S060 
S062 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 S094 S095 S096 S097 
S098 S099 S100 S101 S102 S103 S104 S105 S106 S107 S108 S109 
S110 S111 S112 S113 S114 S115 S116 S117 S118 S119 S120 S121 
S122 S123 S124 S125 S126 S127 S128 S129 S130 S133 S135