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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.
 
DeviceSYMPHONY/ELA RHAPSODY PACEMAKER SYSTEM
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMicroPort CRM USA Inc.
5640 Airline Road
Arlington, TN 38002
PMA NumberP950029
Supplement NumberS017
Date Received12/23/2002
Decision Date10/24/2003
Product Code DXY 
Advisory Committee Cardiovascular
Supplement TypeNormal 180 Day Track
Supplement Reason Change Design/Components/Specifications/Material
Expedited Review Granted? No
Combination ProductNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR NEW PACEMAKER MODELS, SYMPHONY MODELS 2550, AND 2250 AND ELA RHAPSODY MODELS 2530, 2510 AND 2210. THE SYMPHONY AND ELA RHAPSODY PACEMAKER SYSTEMS ARE INDICATED FOR: 1) RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION AND/OR ACTIVITY. 2) THE ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE, BUT ARE NOT RESTRICTED TO: A) SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND- OR THIRD-DEGREE AV BLOCK; B) SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; C) SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS: D) BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; E) VASOVAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. IN ADDITION, THE DUAL-CHAMBER AND ATRIAL TRACKING MODES (SYMPOHONY DR MODEL 2550 AND ELA RHAPSODY DR MODELS 2530 AND 2510) ARE INDICATED FOR PATITNES 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 TO CARDIAC OUTPUT; AND 2) VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.
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