Premarket Approval (PMA)

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.

• Device: VIGOR(TM) DR PACEMAKER SYSTEM
• Generic Name: implantable pacemaker Pulse-generator
• Regulation Number: 870.3610
• Applicant: BOSTON SCIENTIFIC; 4100 Hamline Avenue North; St. Paul, MN 55112
• PMA Number: P940031
• Date Received: 09/30/1994
• Decision Date: 06/21/1995
• Product Code: 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 S074 S077 ; S070 S071 S047 S049 S018 S072 S032 S033 S034 S012 S013 S028 ; S029 S030 S025 S026 S061 S022 S023 S024 S059 S060 S066 S019 ; S020 S021 S065 S045 S046 S014 S015 S016 S017 S010 S011 S075 ; S076 S073 S027 S035 S036 S037 S038 S039 S040 S042 S043 S044 ; S050 S051 S052 S053 S054 S055 S057 S031 S068 S069 S067 S062 ; S063 S064 S078 S079