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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 NameVIGOR(TM) DR PACEMAKER SYSTEM
Classification Nameimplantable pacemaker pulse-generator
Generic Namedual-chamber adaptive-rate pacemaker
Regulation Number870.3610
ApplicantBOSTON SCIENTIFIC
PMA NumberP940031
Date Received09/30/1994
Decision Date06/21/1995
Product Code
DXY[ Registered Establishments with DXY ]
Docket Number 96M-0451
Notice Date 11/29/1996
Advisory Committee Cardiovascular
Expedited Review Granted? No
Combination Product No
Supplements: S001 S002 S003 S004 S005 S006 S007 S008 S009 
S010 S011 S012 S013 S014 S015 S016 S017 S018 
S019 S020 S021 S022 S023 S024 S025 S026 S027 
S028 S029 S030 S031 S032 S033 S034 S035 S036 
S037 S038 S039 S040 S042 S043 S044 S045 S046 
S047 S049 S050 S051 S052 S053 S054 S055 S057 
S059 S060 S061 S062 S063 S064 S065 S066 S067 
S068 S069 S070 S071 S072 S073 S074 S075 S076 
S077 
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