Premarket Approval (PMA)

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.

• Device: IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
• Generic Name: Implantable pulse generator, pacemaker (non-CRT)
• Applicant: BOSTONSCIENTIFIC; 4100 HAMLINE AVENUE NORTH; ST PAUL, MN 55112
• PMA Number: P150012
• Date Received: 03/03/2015
• Decision Date: 04/25/2016
• Product Codes: LWP NVN
• Docket Number: 16M-1222
• Notice Date: 05/11/2016
• Advisory Committee: Cardiovascular
• Clinical Trials: NCT00907361
• Expedited Review Granted?: No
• Combination Product: Yes
• Recalls: CDRH 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 Order: Approval Order
• Summary: Summary of Safety and Effectiveness
• Labeling: Labeling; Labeling Part 2
• Post-Approval Study: Show 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 S131 S132 S133 ; S134 S135 S136 S137 S138 S139 S140 S141 S142 S143 S144 S145 ; S146 S147 S148 S149 S150 S151 S152 S154