IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD

Implantable Pulse Generator, Pacemaker (non-crt)

FDA Premarket Approval P150012

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.

Pre-market Approval Supplement Details

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.

DeviceIMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD
Classification NameImplantable Pulse Generator, Pacemaker (non-crt)
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantBOSTONSCIENTIFIC
Date Received2015-03-03
Decision Date2016-04-25
Notice Date2016-05-11
PMAP150012
SupplementS
Product CodeLWP
Docket Number16M-1222
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product Yes
Applicant Address BOSTONSCIENTIFIC 4100 Hamline Avenue North st Paul, MN 55112
Summary:Summary of Safety and Effectiveness
Labeling: Labeling Labeling Part 2
Post-Approval Study:Show Report Schedule and Study Progress
Approval Order: Approval Order

Supplemental Filings

Supplement NumberDateSupplement Type
P150012Original Filing
S138 2022-12-12 30-day Notice
S137 2022-12-09 30-day Notice
S136 2022-12-07 30-day Notice
S135 2022-11-01 30-day Notice
S134
S133 2022-10-05 30-day Notice
S132
S131
S130 2022-09-20 30-day Notice
S129
S128 2022-07-21 30-day Notice
S127 2022-07-21 30-day Notice
S126 2022-06-29 30-day Notice
S125
S124 2022-03-28 30-day Notice
S123 2022-02-23 30-day Notice
S122 2021-12-16 30-day Notice
S121 2021-12-07 30-day Notice
S120
S119 2021-10-08 30-day Notice
S118 2021-09-30 30-day Notice
S117 2021-09-23 30-day Notice
S116
S115 2021-09-01 30-day Notice
S114 2021-06-21 Real-time Process
S113 2021-06-16 30-day Notice
S112
S111 2021-04-30 30-day Notice
S110 2021-04-28 30-day Notice
S109 2021-04-26 30-day Notice
S108 2021-03-24 30-day Notice
S107 2021-03-08 30-day Notice
S106 2021-01-11 30-day Notice
S105 2020-12-08 30-day Notice
S104
S103 2020-10-21 30-day Notice
S102 2020-10-01 30-day Notice
S101 2020-09-24 30-day Notice
S100 2020-08-13 Real-time Process
S099
S098 2020-08-06 30-day Notice
S097 2020-07-27 30-day Notice
S096
S095 2020-05-22 Normal 180 Day Track No User Fee
S094 2020-04-30 30-day Notice
S093 2020-04-10 30-day Notice
S092
S091 2020-03-13 30-day Notice
S090 2020-03-02 30-day Notice
S089 2020-01-27 30-day Notice
S088
S087 2019-12-03 30-day Notice
S086 2019-11-22 30-day Notice
S085
S084 2019-10-21 30-day Notice
S083
S082 2019-09-10 30-day Notice
S081
S080 2019-06-20 Real-time Process
S079 2019-05-31 30-day Notice
S078
S077 2019-04-25 30-day Notice
S076
S075 2019-03-20 Real-time Process
S074 2019-03-13 30-day Notice
S073
S072 2019-02-15 30-day Notice
S071 2019-02-11 30-day Notice
S070 2018-12-26 Real-time Process
S069 2018-12-20 30-day Notice
S068
S067 2018-12-03 Real-time Process
S066 2018-10-19 30-day Notice
S065 2018-10-11 30-day Notice
S064 2018-07-13 30-day Notice
S063 2018-06-11 30-day Notice
S062 2018-05-04 Real-time Process
S061
S060 2018-04-30 Normal 180 Day Track
S059 2018-04-25 30-day Notice
S058 2018-03-26 30-day Notice
S057
S056 2018-03-20 30-day Notice
S055 2018-03-13 30-day Notice
S054 2018-02-16 30-day Notice
S053 2018-01-19 30-day Notice
S052 2018-01-18 Real-time Process
S051 2017-12-14 Real-time Process
S050 2017-11-21 30-day Notice
S049 2017-11-21 30-day Notice
S048 2017-11-20 30-day Notice
S047 2017-11-17 30-day Notice
S046 2017-11-13 30-day Notice
S045 2017-11-02 30-day Notice
S044 2017-10-20 Real-time Process
S043 2017-09-15 Real-time Process
S042 2017-09-29 30-day Notice
S041 2017-09-28 30-day Notice
S040 2017-09-27 30-day Notice
S039 2017-04-03 Normal 180 Day Track
S038 2017-09-05 30-day Notice
S037 2017-09-05 30-day Notice
S036 2017-08-04 30-day Notice
S035 2017-08-02 30-day Notice
S034 2017-07-24 Real-time Process
S033 2017-07-17 Real-time Process
S032 2017-05-26 Normal 180 Day Track
S031 2017-05-01 Normal 180 Day Track
S030 2017-04-26 30-day Notice
S029 2017-04-25 30-day Notice
S028 2017-04-07 30-day Notice
S027 2017-03-30 30-day Notice
S026 2017-03-17 30-day Notice
S025 2016-12-21 30-day Notice
S024 2016-12-19 30-day Notice
S023 2016-12-14 30-day Notice
S022 2016-12-13 30-day Notice
S021 2016-12-09 Normal 180 Day Track
S020 2016-11-18 30-day Notice
S019 2016-11-14 30-day Notice
S018 2016-11-03 30-day Notice
S017 2016-10-03 30-day Notice
S016 2016-09-12 30-day Notice
S015 2016-09-02 30-day Notice
S014 2016-08-17 30-day Notice
S013 2016-07-29 Real-time Process
S012 2016-07-22 30-day Notice
S011 2016-07-07 30-day Notice
S010 2016-07-05 30-day Notice
S009 2016-06-27 30-day Notice
S008 2016-05-27 30-day Notice
S007 2016-05-26 30-day Notice
S006 2016-05-20 135 Review Track For 30-day Notice
S005 2016-05-18 30-day Notice
S004 2016-05-06 Real-time Process
S003 2016-05-04 30-day Notice
S002 2016-05-02 30-day Notice
S001 2016-04-27 30-day Notice

NIH GUDID Devices

Device IDPMASupp
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00802526523458 P150012 000
00802526523427 P150012 000
00802526523397 P150012 000
00802526523366 P150012 000
00802526523335 P150012 000
00802526523304 P150012 000
00802526497803 P150012 000
00802526558948 P150012 000
00802526558962 P150012 000
00802526559006 P150012 000
00802526579455 P150012 000
00802526579448 P150012 000
00802526579431 P150012 000
00802526579424 P150012 000
00802526579417 P150012 000
00802526559266 P150012 000
00802526559228 P150012 000
00802526559204 P150012 000
00802526604577 P150012 083
00802526604522 P150012 083
00802526604430 P150012 083

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