COSMOS System

FDA Premarket Approval P830026 S083

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

DeviceCOSMOS System
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received2021-03-08
Decision Date2021-04-02
PMAP830026
SupplementS083
Product CodeLWP 
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
P830026Original Filing
S083 2021-03-08 30-day Notice
S082 2013-08-29 30-day Notice
S081 2012-11-08 30-day Notice
S080 0000-00-00
S079 2004-12-03 30-day Notice
S078
S077 0000-00-00
S076 0000-00-00
S075 0000-00-00
S074 0000-00-00
S073 0000-00-00
S072
S071 1998-02-19 Normal 180 Day Track
S070 0000-00-00
S069 0000-00-00
S068
S067 0000-00-00
S066 0000-00-00
S065 0000-00-00
S064 0000-00-00
S063 1994-12-20 Normal 180 Day Track
S062 0000-00-00
S061 1994-04-25 Normal 180 Day Track
S060 0000-00-00
S059 1993-11-04 Normal 180 Day Track
S058 0000-00-00
S057 0000-00-00
S056 0000-00-00
S055 0000-00-00
S054 0000-00-00
S053 0000-00-00
S052 0000-00-00
S051 0000-00-00
S050
S049 0000-00-00
S048 0000-00-00
S047 0000-00-00
S046 0000-00-00
S045 0000-00-00
S044 0000-00-00
S043 1990-05-08 Normal 180 Day Track
S042 0000-00-00
S041 0000-00-00
S040 0000-00-00
S039 0000-00-00
S038 0000-00-00
S037 0000-00-00
S036 0000-00-00
S035 0000-00-00
S034 0000-00-00
S033 0000-00-00
S032 0000-00-00
S031 0000-00-00
S030 0000-00-00
S029 0000-00-00
S028 0000-00-00
S027
S026 0000-00-00
S025 0000-00-00
S024 0000-00-00
S023 0000-00-00
S022 1987-01-15 Normal 180 Day Track
S021 0000-00-00
S020 0000-00-00
S019 0000-00-00
S018 0000-00-00
S017 0000-00-00
S016 1986-05-06
S015 0000-00-00
S014 0000-00-00
S013 0000-00-00
S012 0000-00-00
S011 0000-00-00
S010 0000-00-00
S009 0000-00-00
S008 1985-02-21
S007 0000-00-00
S006 0000-00-00
S005 0000-00-00
S004
S003 0000-00-00
S002 0000-00-00
S001 1984-07-02

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