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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.
 
DeviceCHORUS RM MODEL 7034 DDDR PACEMAKER INCL. OPUS RM MODEL 4534 SSIR PACEMAKER
Generic Nameimplantable pacemaker Pulse-generator
Regulation Number870.3610
ApplicantMicroPort CRM USA, Inc.
5640 Airline Rd..
Arlington, TN 38002
PMA NumberP950029
Date Received08/02/1995
Decision Date03/10/1997
Product Code DXY 
Docket Number 97M-0185
Notice Date 05/19/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination ProductNo
Predetermined Change Control Plan AuthorizedNo
RecallsCDRH Recalls
Approval Order Statement  
APPROVAL FOR THE CHORUS RM MODEL 7034 DDDR PACEMAKER SYSTEM AND OPUS RM MODEL 4534 SSIR PACEMAKER SYSTEM WHICH INCLUDES AN IBM COMPATIBLE MICROCOMPUTER WHICH HAS BEEN CONFIGURED AND FURNISHED BY ELA MEDICAL, INC. WITH CSO 2.46 PROGRAMMING SOFTWARE AND IS CONNECTED TO A CPR1 PROGRAMMING HEAD. THESE DEVICES ARE INDICATED FOR: RATE ADAPTIVE PACING IN PATIENTS WHO MAY BENEFIT FROM INCREASED PACING RATES CONCURRENT WITH INCREASES IN MINUTE VENTILATION; AND THE GENERALLY ACCEPTED PATIENT CONDITIONS WARRANTING CHRONIC CARDIAC PACING WHICH INCLUDE: *SYMPTOMATIC PAROXYSMAL OR PERMANENT SECOND OR THIRD-DEGREEE AV BLOCK; *SYMPTOMATIC BILATERAL BUNDLE BRANCH BLOCK; *SYMPTOMATIC PAROXYSMAL OR TRANSIENT SINUS NODE DYSFUNCTIONS WITH OR WITHOUT ASSOCIATED AV CONDUCTION DISORDERS; *BRADYCARDIA-TACHYCARDIA SYNDROME TO PREVENT SYMPTOMATIC BRADYCARDIA OR SOME FORMS OF SYMPTOMATIC TACHYARRHYTHMIAS; AND *VASO-VAGAL SYNDROMES OR HYPERSENSITIVE CAROTID SINUS SYNDROMES. THE CHROUS RM 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: *VARIOUS DEGREES OF AV BLOCK TO MAINTAIN THE ATRIAL CONTRIBUTION TO CARDIAC OUTPUT; AND *VVI INTOLERANCE (E.G., PACEMAKER SYNDROME) IN THE PRESENCE OF PERSISTENT SINUS RHYTHM.
Supplements: S060 S056 S057  S058 S061 S062 S047 S051 S054 S038 S039 
S030 S041 S042 S043 S064 S052 S086 S108 S069 S070 S071 S083 
S084 S079 S094 S095 S092 S093 S046 S029 S014 S016 S021 S022 
S023 S006 S007 S008 S020 S037 S019 S025 S001 S002 S003 S005 
S036 S050 S031 S032 S013 S010 S011 S012 S027 S028 S026 S113 
S111 S009 S082 S067 S087 S088 S089 S096 S097 S098 S106 S107 
S073 S074 S075 S076 S077 S102 S103 S104 S068 S091 S072 S099 
S100 S101 S085 S090 S105 S065 S066 S078 S080 S015 S017 S024 
S033 S034 S040 S048 S049 S055 S044 S045 S053 S109 S112 S110 
S114 S115 S116 S120 S127 S124 S131 S134 S121 S122 S117 S118 
S119 S123 S126 S128 S129 S125 S132 S130 S133 
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