NOVA II MODEL 282-04Y PULSE GENERATOR

FDA Premarket Approval P830026 S046

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

DeviceNOVA II MODEL 282-04Y PULSE GENERATOR
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received1991-03-25
Decision Date1991-05-16
PMAP830026
SupplementS046
Product CodeLWP 
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonChange Design/components/specifications/material
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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