COSMOS(TM) SYSTEM

FDA Premarket Approval P830026 S007

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

DeviceCOSMOS(TM) SYSTEM
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received1985-02-15
Decision Date1985-07-10
PMAP830026
SupplementS007
Product CodeLWP 
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P830026Original Filing
S083 2021-03-08 30-day Notice
S082 2013-08-29 30-day Notice
S081 2012-11-08 30-day Notice
S080 2012-03-24 30-day Notice
S079 2004-12-03 30-day Notice
S078 2004-10-21 30-day Notice
S077 1999-10-25 Normal 180 Day Track
S076 1999-10-07 Real-time Process
S075 1999-09-07 Normal 180 Day Track
S074 1998-10-09 Normal 180 Day Track
S073 1998-07-01 Real-time Process
S072
S071 1998-02-19 Normal 180 Day Track
S070 1997-03-14 Normal 180 Day Track
S069 1997-03-06 Normal 180 Day Track
S068
S067 1996-03-08 Normal 180 Day Track
S066 1996-02-01 Special (immediate Track)
S065 1995-12-12 Normal 180 Day Track
S064 1995-09-18 Normal 180 Day Track
S063 1994-12-20 Normal 180 Day Track
S062 1994-12-05 Normal 180 Day Track
S061 1994-04-25 Normal 180 Day Track
S060 1993-11-30 Normal 180 Day Track
S059 1993-11-04 Normal 180 Day Track
S058 1993-06-17 Normal 180 Day Track
S057 1992-08-05 Normal 180 Day Track
S056 1992-07-24 Normal 180 Day Track
S055 1992-07-10 Normal 180 Day Track
S054 1992-05-11 Normal 180 Day Track
S053 1992-02-12 Normal 180 Day Track
S052 1991-12-24 Normal 180 Day Track
S051 1991-12-24 Normal 180 Day Track
S050
S049 1991-05-20 Normal 180 Day Track
S048 1991-05-14 Normal 180 Day Track
S047 1991-05-10 Normal 180 Day Track
S046 1991-03-25 Normal 180 Day Track
S045 1991-03-25 Normal 180 Day Track
S044 1990-05-08 Normal 180 Day Track
S043 1990-05-08 Normal 180 Day Track
S042 1990-05-08 Normal 180 Day Track
S041 1990-05-08 Normal 180 Day Track
S040 1990-05-08 Normal 180 Day Track
S039 1989-09-15 Normal 180 Day Track
S038 1989-03-16 Normal 180 Day Track
S037 1988-11-04 Normal 180 Day Track
S036 1988-08-23 Normal 180 Day Track
S035 1988-08-09 Normal 180 Day Track
S034 1988-07-11 Normal 180 Day Track
S033 1987-09-22 Normal 180 Day Track
S032 1987-07-01 Normal 180 Day Track
S031 1987-06-30 Normal 180 Day Track
S030 1987-06-05 Normal 180 Day Track
S029 1987-05-12 Special (immediate Track)
S028 1987-04-13 Normal 180 Day Track
S027
S026 1987-03-11 Normal 180 Day Track
S025 1987-03-04 Normal 180 Day Track
S024 1987-02-24 Normal 180 Day Track
S023 1987-01-27 Normal 180 Day Track
S022 1987-01-15 Normal 180 Day Track
S021 1986-11-05 Special (immediate Track)
S020 1986-10-17 Normal 180 Day Track
S019 1986-09-26 Special (immediate Track)
S018 1986-07-02 Normal 180 Day Track
S017 1986-06-02 Normal 180 Day Track
S016 1986-05-06
S015 1986-02-18
S014 1985-12-23
S013 1985-12-17
S012 1985-09-27
S011 1985-07-22
S010 1985-06-17
S009 1985-03-06
S008 1985-02-21
S007 1985-02-15
S006 1985-01-22
S005 1984-11-29
S004
S003 1984-10-03
S002 1984-08-16
S001 1984-07-02

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