FINELINE II Steroid-Eluting Pacing Leads

FDA Premarket Approval P960004 S091

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

Updates to manufacturing work instructions and tool inspection for the cathode coil threading process for the fineline ii steroid-eluting pacing leads

DeviceFINELINE II Steroid-Eluting Pacing Leads
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantBOSTON SCIENTIFIC
Date Received2020-09-02
Decision Date2020-09-25
PMAP960004
SupplementS091
Product CodeNVN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address BOSTON SCIENTIFIC 4100 Hamline Avenue North st. Paul, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P960004Original Filing
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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