MODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD

Implantable Pulse Generator, Pacemaker (non-crt)

FDA Premarket Approval P840068 S011

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

DeviceMODEL 446 & 447 VISTA T PU.GEN. MODEL 2046 SOF.MOD
Classification NameImplantable Pulse Generator, Pacemaker (non-crt)
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received1990-01-25
Decision Date1990-02-21
PMAP840068
SupplementS011
Product CodeLWP
Advisory CommitteeCardiovascular
Supplement TypeNormal 180 Day Track
Supplement ReasonOther Report
Expedited ReviewNo
Combination Product No
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P840068Original Filing
S055 2021-03-08 30-day Notice
S054 2019-03-13 30-day Notice
S053 2013-08-29 30-day Notice
S052 2012-11-08 30-day Notice
S051 2012-10-10 30-day Notice
S050 2012-03-24 30-day Notice
S049 2011-04-01 30-day Notice
S048 2011-03-18 Real-time Process
S047 2010-08-23 Real-time Process
S046 2007-08-23 Normal 180 Day Track
S045
S044 2006-06-26 30-day Notice
S043 2004-12-03 30-day Notice
S042 2004-10-21 30-day Notice
S041 2001-04-06 Real-time Process
S040 2000-07-25 Normal 180 Day Track
S039 1999-12-20 Normal 180 Day Track
S038 1999-10-06 Real-time Process
S037 1998-08-05 Real-time Process
S036 1998-06-24 Real-time Process
S035 1998-05-07 Real-time Process
S034 1998-03-04 Real-time Process
S033 1997-07-18 Real-time Process
S032 1996-12-23 Normal 180 Day Track
S031 1997-01-17 Normal 180 Day Track
S030 1996-10-16 Normal 180 Day Track
S029 1996-03-25 Normal 180 Day Track
S028 1995-09-11 Normal 180 Day Track
S027 1995-08-09 Normal 180 Day Track
S026 1995-06-26 Normal 180 Day Track
S025 1995-04-06 Normal 180 Day Track
S024 1995-03-16 Normal 180 Day Track
S023 1994-12-14 Normal 180 Day Track
S022 1993-07-13 Normal 180 Day Track
S021 1993-07-13 Normal 180 Day Track
S020 1992-07-27 Normal 180 Day Track
S019 1992-05-05 Normal 180 Day Track
S018 1992-04-08 Normal 180 Day Track
S017 1991-11-07 Normal 180 Day Track
S016 1991-10-17 Normal 180 Day Track
S015 1991-07-02 Normal 180 Day Track
S014 1990-07-20 Normal 180 Day Track
S013 1990-07-17 Normal 180 Day Track
S012 1990-02-15 Normal 180 Day Track
S011 1990-01-25 Normal 180 Day Track
S010 1989-12-21 Normal 180 Day Track
S009 1989-10-31 Normal 180 Day Track
S008 1989-10-23 Normal 180 Day Track
S007 1988-08-02 Normal 180 Day Track
S006 1988-05-16 Normal 180 Day Track
S005 1988-04-04 Normal 180 Day Track
S004 1987-10-06 Normal 180 Day Track
S003 1986-11-24 Normal 180 Day Track
S002 1986-03-20
S001 1986-01-16

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