THINLINE ENDOCARDIAL PACING LEADS

Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes

FDA Premarket Approval P960004

This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.

Pre-market Approval Supplement Details

Approval for the thinline(tm) models 430-10 and 432-04 endocardial pacing leads indicated for chronic pacing and sensing of the atrium or ventricle when used with a compatible pulse generator

DeviceTHINLINE ENDOCARDIAL PACING LEADS
Classification NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantBOSTON SCIENTIFIC
Date Received1996-01-29
Decision Date1996-11-12
Notice Date1997-07-02
PMAP960004
SupplementS
Product CodeNVN
Docket Number97M-0258
Advisory CommitteeCardiovascular
Expedited ReviewNo
Combination Product Yes
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P960004Original Filing
S101 2022-11-01 30-day Notice
S100 2022-07-26 30-day Notice
S099 2022-02-23 30-day Notice
S098 2021-09-30 30-day Notice
S097 2021-09-30 30-day Notice
S096 2021-09-23 30-day Notice
S095 2021-09-01 30-day Notice
S094 2021-04-30 30-day Notice
S093 2021-03-08 30-day Notice
S092 2021-01-11 30-day Notice
S091 2020-09-02 30-day Notice
S090 2019-05-03 Normal 180 Day Track
S089 2019-03-13 30-day Notice
S088 2018-12-26 Real-time Process
S087 2018-12-20 30-day Notice
S086 2018-07-13 30-day Notice
S085 2018-04-30 Normal 180 Day Track
S084 2018-04-25 30-day Notice
S083 2018-03-26 30-day Notice
S082 2018-01-11 30-day Notice
S081 2017-05-26 Normal 180 Day Track
S080 2017-04-26 30-day Notice
S079 2017-03-30 30-day Notice
S078 2016-12-09 Normal 180 Day Track
S077 2016-07-07 30-day Notice
S076 2016-05-27 30-day Notice
S075 2015-11-20 135 Review Track For 30-day Notice
S074 2015-09-17 30-day Notice
S073 2015-09-01 30-day Notice
S072 2015-07-21 30-day Notice
S071
S070 2015-06-22 30-day Notice
S069 2015-06-05 30-day Notice
S068 2015-04-20 30-day Notice
S067 2014-11-25 30-day Notice
S066 2014-06-30 30-day Notice
S065 2014-04-22 30-day Notice
S064 2013-11-08 30-day Notice
S063 2013-08-29 30-day Notice
S062
S061 2013-05-16 Real-time Process
S060 2013-06-26 Normal 180 Day Track
S059 2013-03-27 Normal 180 Day Track
S058 2012-11-08 30-day Notice
S057 2012-10-02 30-day Notice
S056 2012-09-10 30-day Notice
S055 2012-09-04 30-day Notice
S054 2012-07-26 Real-time Process
S053 2012-06-19 Real-time Process
S052 2012-06-18 30-day Notice
S051 2012-03-26 30-day Notice
S050 2012-01-24 30-day Notice
S049 2011-04-01 30-day Notice
S048 2011-02-22 30-day Notice
S047
S046 2010-08-23 30-day Notice
S045 2009-12-18 30-day Notice
S044 2009-12-16 30-day Notice
S043
S042 2008-12-08 Real-time Process
S041 2008-08-25 Real-time Process
S040
S039 2007-03-19 Real-time Process
S038 2006-08-01 135 Review Track For 30-day Notice
S037
S036 2006-04-13 30-day Notice
S035 2006-04-13 30-day Notice
S034 2006-02-09 30-day Notice
S033
S032 2005-12-22 30-day Notice
S031 2005-12-22 30-day Notice
S030 2005-12-22 30-day Notice
S029 2005-12-20 30-day Notice
S028 2005-02-24 30-day Notice
S027 2004-12-03 30-day Notice
S026 2004-10-21 30-day Notice
S025 2004-04-14 30-day Notice
S024 2004-01-13 30-day Notice
S023 2003-12-03 Special (immediate Track)
S022 2003-06-03 30-day Notice
S021 2002-11-13 30-day Notice
S020 2001-11-16 Real-time Process
S019 2001-10-04 Real-time Process
S018 2001-02-20 Real-time Process
S017 2000-12-26 Normal 180 Day Track
S016
S015 2000-08-21 Normal 180 Day Track
S014 2000-05-26 Normal 180 Day Track
S013 2000-05-15 Normal 180 Day Track
S012 2000-05-15 30-day Notice
S011 2000-01-11 Real-time Process
S010 1999-09-14 Normal 180 Day Track
S009 1999-10-25 Normal 180 Day Track
S008 1999-08-31 Normal 180 Day Track
S007 1999-08-31 135 Review Track For 30-day Notice
S006 1999-06-23 Normal 180 Day Track
S005 1999-06-14 Real-time Process
S004
S003
S002 1997-04-17 Normal 180 Day Track
S001 1997-01-27 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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00802526060953 P960004 039
00802526060915 P960004 039

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