VIGOR(TM) DR PACEMAKER SYSTEM

Implantable Pacemaker Pulse-generator

FDA Premarket Approval P940031

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.

Pre-market Approval Supplement Details

DeviceVIGOR(TM) DR PACEMAKER SYSTEM
Classification NameImplantable Pacemaker Pulse-generator
Generic NameImplantable Pacemaker Pulse-generator
ApplicantBOSTON SCIENTIFIC
Date Received1994-09-30
Decision Date1995-06-21
Notice Date1996-11-29
PMAP940031
SupplementS
Product CodeDXY
Docket Number96M-0451
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P940031Original Filing
S079 2021-03-08 30-day Notice
S078 2019-03-13 30-day Notice
S077 2014-04-22 30-day Notice
S076 2014-02-21 Real-time Process
S075 2013-08-29 30-day Notice
S074 2012-11-08 30-day Notice
S073 2012-10-02 30-day Notice
S072 2012-03-26 30-day Notice
S071 2011-04-01 30-day Notice
S070 2011-03-18 Real-time Process
S069 2010-08-23 Real-time Process
S068 2010-07-15 30-day Notice
S067 2010-04-20 30-day Notice
S066 2010-02-04 30-day Notice
S065 2009-05-22 135 Review Track For 30-day Notice
S064 2008-06-18 30-day Notice
S063 2008-06-03 30-day Notice
S062 2007-11-09 30-day Notice
S061 2007-08-23 Normal 180 Day Track
S060 2006-11-06 30-day Notice
S059 2006-11-01 Real-time Process
S058
S057 2006-06-26 30-day Notice
S056
S055 2006-05-12 Normal 180 Day Track
S054 2006-05-02 135 Review Track For 30-day Notice
S053 2006-04-13 30-day Notice
S052 2006-03-28 30-day Notice
S051 2006-03-03 30-day Notice
S050 2006-03-03 135 Review Track For 30-day Notice
S049 2005-12-21 30-day Notice
S048
S047 2005-11-16 30-day Notice
S046 2005-10-11 135 Review Track For 30-day Notice
S045 2005-10-03 135 Review Track For 30-day Notice
S044 2005-08-29 135 Review Track For 30-day Notice
S043 2005-08-25 30-day Notice
S042 2005-08-15 30-day Notice
S041
S040
S039 2005-08-09 30-day Notice
S038 2005-06-27 30-day Notice
S037 2005-06-27 30-day Notice
S036 2005-06-27 30-day Notice
S035 2005-06-23 30-day Notice
S034 2005-03-18 Real-time Process
S033 2004-12-03 30-day Notice
S032 2004-10-21 30-day Notice
S031 2004-04-14 30-day Notice
S030 2004-01-13 30-day Notice
S029 2003-11-20 30-day Notice
S028 2003-09-08 Real-time Process
S027 2002-12-12 Normal 180 Day Track
S026 2001-04-06 Real-time Process
S025 2001-01-19 Real-time Process
S024 2000-05-09 Real-time Process
S023 1999-12-20 Normal 180 Day Track
S022 2000-01-27 Real-time Process
S021 1999-10-04 Real-time Process
S020 1999-09-30 Real-time Process
S019 1999-06-07 Normal 180 Day Track
S018 1999-03-03 Real-time Process
S017 1998-07-30 Real-time Process
S016 1998-08-24 Real-time Process
S015 1998-07-01 Normal 180 Day Track
S014 1998-08-05 Real-time Process
S013 1998-05-07 Real-time Process
S012 1998-03-04 Real-time Process
S011 1997-10-24 Normal 180 Day Track
S010 1997-07-18 Real-time Process
S009 1996-12-23 Normal 180 Day Track
S008 1997-01-17 Normal 180 Day Track
S007 1996-11-20 Normal 180 Day Track
S006 1996-10-16 Normal 180 Day Track
S005 1996-03-25 Normal 180 Day Track
S004 1996-01-25 Normal 180 Day Track
S003 1995-09-11 Normal 180 Day Track
S002 1995-08-09 Normal 180 Day Track
S001 1995-06-26 Normal 180 Day Track

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