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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 may have changed. Be sure to look at the supplements to get an up-to-date view of this device.
 
Trade NameDROMOS DR/DR-A AND DROMOS SR/SR-B CARDIAC PACING SYSTEMS
Classification Nameimplantable pacemaker pulse-generator
Generic Nameimplantable pacemaker pulse generator, pacemaker programmer
Regulation Number870.3610
ApplicantBIOTRONIK, INC.
PMA NumberP950037
Date Received11/16/1995
Decision Date10/11/1996
Product Code
DXY[ Registered Establishments with DXY ]
Docket Number 97M-0251
Notice Date 07/02/1997
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Approval Order Statement 
Rate adaptive pacing with the dromos dr and dromos sr pulse generators is indicated for patients exhibiting chronotropic incompetence and who would benefit from increased pacing rates concurrent with physical activity.
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S011 S012 S013 S014 S015 S016 S017 S018 S019 
S020 S021 S022 S023 S024 S028 S029 S030 S031 
S032 S033 S034 S035 S036 S037 S038 S039 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 S076 S077 S078 
S079 S080 S081 S082 S083 S084 S085 S086 S088 
S089 S090 S091 S092 S094 S095 S096 S097 S098 
S099 S100 S101 S102 S103 S104 S105 S107 S108 
S109 S110 S111 S112 S113 S114 S116 S117 S118 
S119 S121 S122 S123 S124 S125 S126 S127 S128 
S129 S130 S131 S132 S133 S134 S135 S136 S138 
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