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.
| Device | IMAGEREADY MR CONDITIONAL PACING SYSTEM AND INGEVITY PACE/SENSE LEAD |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | BOSTONSCIENTIFIC |
| Date Received | 2015-03-03 |
| Decision Date | 2016-04-25 |
| Notice Date | 2016-05-11 |
| PMA | P150012 |
| Supplement | S |
| Product Code | LWP |
| Docket Number | 16M-1222 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| 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 Number | Date | Supplement Type |
|---|
| P150012 | | Original 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