Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Premarket Approval (PMA)
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back to Search Results
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
Generic NameImplantable pulse generator, pacemaker (non-CRT)
ApplicantAbbott Medical
15900 Valley View Court
Sylmar, CA 91335
PMA NumberP140033
Date Received12/24/2014
Decision Date01/31/2017
Product Codes LWP NVN 
Docket Number 17M-0661
Notice Date 03/10/2017
Advisory Committee Cardiovascular
Clinical TrialsNCT01576016
Expedited Review Granted? No
Combination ProductYes
RecallsCDRH Recalls
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 OrderApproval Order
SummarySummary of Safety and Effectiveness
LabelingLabeling
Labeling Part 2
Post-Approval StudyShow 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 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 S057 S058 S059 S060 
S061 S062 S063 S064 S065 S066 S067 S068 S069 S070 S071 S072 
S073 S074 S075 S076 S077 S078 S079 S080 S081 S082 S083 S085 
S087 
-
-