DELTA/VISTA

FDA Premarket Approval P840068 S055

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

DeviceDELTA/VISTA
Generic NameImplantable Pulse Generator, Pacemaker (non-crt)
ApplicantBOSTON SCIENTIFIC
Date Received2021-03-08
Decision Date2021-04-02
PMAP840068
SupplementS055
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
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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