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U.S. Department of Health and Human Services

Premarket Approval (PMA)
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Note: This medical device record is a PMA supplement. A supplement may have changed the device description/function or indication from that approved in the original PMA. Be sure to look at the original PMA record for more information.
 
DeviceCARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER
Generic NamePulse generator, permanent, implantable
ApplicantMedtronic, Inc.
8200 CORAL SEA STREET N.E.
MOUNDS VIEW, MN 55112
PMA NumberP890003
Supplement NumberS252
Date Received06/29/2012
Decision Date01/15/2013
Product Code NVZ 
Advisory Committee Cardiovascular
Clinical TrialsNCT00433654
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
Approval Order Statement  
APPROVAL OF AN MR-CONDITIONAL SYSTEM PERMITTING IMPLANTED PATIENTS TO UNDERGO MRI SCANS PROVIDED SPECIFIED CONDITIONS ARE MET. THE DEVICES, AS MODIFIED, MAKE UP THE ADVISA DR MRI SURESCAN SYSTEM AND WILL BE MARKETED UNDER THE TRADE NAMES ADVISA DR MRI A2DR01 IMPLANTABLE PULSE GENERATOR WITH SOFTWARE MODEL 9995, CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER MODEL 2020A AND DDMA MODEL 2491. THE ADVISA DR MRI SURESCAN SYSTEM IS INDICATED FOR THE FOLLOWING: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN ACTIVITY; AND2) ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING INCLUDE: A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND-OR THIRD-DEGREE A V BLOCK; B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK;C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITHOR WITHOUT ASSOCIATED A V CONDUCTION DISORDERS D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; AND E) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES THE DEVICE IS ALSO INDICATED FOR DUAL CHAMBER AND ATRIAL TRACKING MODES IN PATIENTS WHO MAY BENEFIT FROM MAINTENANCE OF AV SYNCHRONY. DUAL CHAMBER MODES ARE SPECIFICALLY INDICATED FOR TREATMENT OF CONDUCTION DISORDERS THAT REQUIRE RESTORATION OF BOTH RATE AND AV SYNCHRONY, WHICH INCLUDE:1) VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TOCARDIAC OUTPUT; AND 2) VVI INTOLERANCE (FOR EXAMPLE, PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHMANTITACHYCARDIA PACING (A TP) IS INDICATED FOR TERMINATION OF ATRIALTACHYARRHYTHMIAS IN BRADYCARDIA PATIENTS WITH ONE OR MORE OF THE ABOVE PACING INDICATIONS.
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