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. |
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Device | CARELINK MONITOR MODEL 2490G, CARDIOSIGHT READER |
Generic Name | Pulse generator, permanent, implantable |
Applicant | Medtronic, Inc. 8200 CORAL SEA STREET N.E. MOUNDS VIEW, MN 55112 |
PMA Number | P890003 |
Supplement Number | S252 |
Date Received | 06/29/2012 |
Decision Date | 01/15/2013 |
Product Code |
NVZ |
Advisory Committee |
Cardiovascular |
Clinical Trials | NCT00433654
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Supplement Type | Normal 180 Day Track |
Supplement Reason | Change Design/Components/Specifications/Material |
Expedited Review Granted? | No |
Combination Product | No |
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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