Approval for the mr conditional pacemaker system (which includes the assurity mri (models pm 1272, pm 2272) and endurity mri (models pm 1172, pm 2172) pacemakers, tendril mri lead (model lpa 1200m), mri activator (model ex4000), merlin pcs programmer software (model 3330 v 22. 1. 1), merlin. Net mn5000 7. 4d, and merlin@home ex2000 8. 2. 2). Implantation of a single-chamber pulse generator or dual-chamber pulse generator is indicated for in one or more of the following permananent conditions:1) syncope;2) presyncope;3) fatigue;4) disorientation; or5) any combination of those symptomsmr conditional pulse generator is safe for use in the mri environment when used as a complete mr conditional pacing system, and according to the instructions in the mri procedure information document for the st. Jude medical mr conditional pacing system. Rate-modulated pacing is indicated for patients with chronotropic incompetence, and for those who would benefit from increased stimulation rates concurrent with physical activity. Chronotropic incompetence has not been rigorously defined. A conservative approach, supported by the literature, defines chronotropic incompetence as the failure to achieve an intrinsic heart rate of 70% of the age-predicted maximum heart rate or 120 bpm during exercise testing, whichever is less, where the age-predicted heart rate is calculated as 197 (0. 56 x age). Dual-chamber pacing (dual-chamber pulse generators) is indicated for those patients exhibiting:1) sick sinus syndrome2)chronic, symptomatic second- and third-degree av block3) recurrent adams-stokes syndrome; and4) symptomatic bilateral bundle branch block when tachyarrhythmia and other causes have been ruled out. Atrial pacing is indicated for patients with sinus node dysfunction and normal av and intraventricular conduction systems. Ventricular pacing is indicated for patients with significant bradycardia and:1) normal sinus rhythm with only rare episodes of a-v block or sinus arrest2) chronic atrial fibrillation; and 3) severe physical disabilityaf suppression (dual-chamber pulse generators) is indicated for suppression of paroxysmal or persistent atrial fibrillation episodes in patients with one or more of the above pacing indications. The tendril mri lead is a 7. 9 french, transvenous, steroid eluting, bipolar, is-1 compliant active fixation lead designed for permanent sensing and pacing in either the right atrium or the right ventricle, in combination with a compatible device. Active fixation leads such as the tendril mri lead may be indicated for patients where permanent fixation of passive fixation leads is suspected to be unstable. In atrial applications, the use of screw-in leads such as tendril mri lead may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage. The mri activator handheld device is used to evaluate the status of, and to enable and disable, the previously stored mri settings. The activator is intended for use with st. Jude medical mr conditional pulse generators.
| Device | Assurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software |
| Classification Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Generic Name | Implantable Pulse Generator, Pacemaker (non-crt) |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2014-12-24 |
| Decision Date | 2017-01-31 |
| Notice Date | 2017-03-10 |
| PMA | P140033 |
| Supplement | S |
| Product Code | LWP |
| Docket Number | 17M-0661 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | St. Jude Medical, Inc. 15900 Valley View Court sylmar, CA 91342 |
| 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 |
|---|
| P140033 | | Original Filing |
| S076 |
2022-09-08 |
Real-time Process |
| S075 |
2022-07-27 |
Real-time Process |
| S074 |
2022-07-14 |
30-day Notice |
| S073 |
2022-07-01 |
30-day Notice |
| S072 |
2022-03-07 |
Real-time Process |
| S071 |
2021-10-18 |
Real-time Process |
| S070 |
2021-07-08 |
Normal 180 Day Track |
| S069 |
2021-06-28 |
30-day Notice |
| S068 | | |
| S067 |
2021-04-02 |
Real-time Process |
| S066 |
2021-03-12 |
30-day Notice |
| S065 | | |
| S064 |
2020-11-25 |
30-day Notice |
| S063 |
2020-10-21 |
30-day Notice |
| S062 | | |
| S061 |
2020-09-30 |
30-day Notice |
| S060 | | |
| S059 |
2020-05-22 |
30-day Notice |
| S058 |
2020-04-24 |
30-day Notice |
| S057 |
2020-04-23 |
Normal 180 Day Track No User Fee |
| S056 |
2020-02-27 |
30-day Notice |
| S055 |
2020-02-13 |
30-day Notice |
| S054 | | |
| S053 |
2019-12-10 |
30-day Notice |
| S052 |
2019-12-09 |
30-day Notice |
| S051 |
2019-11-25 |
30-day Notice |
| S050 | | |
| S049 | | |
| S048 | | |
| S047 |
2019-09-26 |
30-day Notice |
| S046 |
2019-07-31 |
30-day Notice |
| S045 |
2019-05-01 |
30-day Notice |
| S044 |
2018-11-30 |
30-day Notice |
| S043 |
2018-11-23 |
30-day Notice |
| S042 |
2018-11-20 |
30-day Notice |
| S041 |
2018-10-29 |
Real-time Process |
| S040 |
2018-10-02 |
30-day Notice |
| S039 |
2018-10-01 |
30-day Notice |
| S038 |
2018-09-28 |
30-day Notice |
| S037 |
2018-09-04 |
30-day Notice |
| S036 |
2018-07-17 |
30-day Notice |
| S035 |
2018-07-02 |
30-day Notice |
| S034 |
2018-06-28 |
Normal 180 Day Track |
| S033 |
2018-06-20 |
Normal 180 Day Track |
| S032 |
2018-05-21 |
30-day Notice |
| S031 | | |
| S030 |
2018-05-01 |
30-day Notice |
| S029 |
2018-04-10 |
30-day Notice |
| S028 |
2018-04-05 |
30-day Notice |
| S027 |
2018-02-27 |
30-day Notice |
| S026 |
2018-02-07 |
30-day Notice |
| S025 |
2018-01-31 |
30-day Notice |
| S024 |
2018-01-29 |
30-day Notice |
| S023 |
2018-01-22 |
Real-time Process |
| S022 |
2018-01-18 |
Normal 180 Day Track |
| S021 | | |
| S020 |
2017-11-29 |
30-day Notice |
| S019 |
2017-11-08 |
Real-time Process |
| S018 |
2017-11-07 |
Normal 180 Day Track |
| S017 |
2017-10-30 |
Real-time Process |
| S016 |
2017-10-10 |
30-day Notice |
| S015 |
2017-09-21 |
30-day Notice |
| S014 |
2017-09-18 |
135 Review Track For 30-day Notice |
| S013 |
2017-08-16 |
30-day Notice |
| S012 |
2017-08-01 |
Real-time Process |
| S011 |
2017-07-31 |
30-day Notice |
| S010 |
2017-07-03 |
Normal 180 Day Track |
| S009 |
2017-06-30 |
30-day Notice |
| S008 |
2017-05-17 |
Normal 180 Day Track |
| S007 |
2017-04-06 |
30-day Notice |
| S006 |
2017-04-03 |
Normal 180 Day Track |
| S005 |
2017-03-06 |
30-day Notice |
| S004 |
2017-02-28 |
30-day Notice |
| S003 |
2017-02-24 |
30-day Notice |
| S002 |
2017-02-17 |
135 Review Track For 30-day Notice |
| S001 |
2017-02-08 |
30-day Notice |
NIH GUDID Devices