VIGOR DR/SR, DISCOVERY, and MERIDIAN

FDA Premarket Approval P940031 S079

This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.

Pre-market Approval Supplement Details

To implement the global labeling system version 3. 0 at select locations

DeviceVIGOR DR/SR, DISCOVERY, and MERIDIAN
Generic NameImplantable Pacemaker Pulse-generator
ApplicantBOSTON SCIENTIFIC
Date Received2021-03-08
Decision Date2021-04-02
PMAP940031
SupplementS079
Product CodeDXY 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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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