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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.
 
DeviceAssurity MRI and Endurity MRI Pacemakers, Tendril MRI Lead, MRI Activator, Merlin PCS Programer Software
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse-generator
Regulation Number870.3610
Applicant
St. Jude Medical, Inc.
15900 valley view court
sylmar, CA 91342
PMA NumberP140033
Date Received12/24/2014
Decision Date01/31/2017
Product Code
DXY[ Registered Establishments with DXY ]
Docket Number 17M-0661
Notice Date 03/10/2017
Advisory Committee Cardiovascular
Clinical Trials NCT01576016
Expedited Review Granted? No
Combination Product Yes
Approval Order Statement 
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.
Approval Order Approval Order
Summary Summary of Safety and Effectiveness
Labeling Labeling
Labeling Part 2
Post-Approval StudyShow Report Schedule and Study Progress
Supplements: S001 S003 S004 S005 S006 S007 S008 S009 S011 
S012 S013 S015 S016 S017 
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