CapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead

FDA Premarket Approval P850089 S147

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

Approval for a change to the lead serial number ink/foil material for select implantable leads.

DeviceCapSure SP Novus Lead, CapSure SP Z Lead, CapSure Z Novus Lead, Vitatron Impulse II Lead
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
Date Received2020-03-23
Decision Date2020-06-02
PMAP850089
SupplementS147
Product CodeNVN 
Advisory CommitteeCardiovascular
Supplement TypeReal-time Process
Supplement ReasonChange Design/components/specifications/material
Expedited ReviewNo
Combination Product Yes
Applicant Address MEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT 8200 Coral Sea Street N.e. mounds View, MN 55112

Supplemental Filings

Supplement NumberDateSupplement Type
P850089Original Filing
S147 2020-03-23 Real-time Process
S146 2020-02-20 30-day Notice
S145 2019-11-18 30-day Notice
S144 2019-09-16 30-day Notice
S143 2019-07-01 30-day Notice
S142 2019-06-20 30-day Notice
S141 2019-06-10 30-day Notice
S140 2019-02-28 30-day Notice
S139 2018-11-21 30-day Notice
S138 2018-10-23 30-day Notice
S137 2018-10-18 30-day Notice
S136 2018-09-26 30-day Notice
S135 2018-06-20 30-day Notice
S134 2018-06-01 30-day Notice
S133 2018-05-15 30-day Notice
S132 2018-04-09 30-day Notice
S131 2018-03-28 30-day Notice
S130 2018-02-22 30-day Notice
S129 2017-11-20 30-day Notice
S128 2017-10-20 30-day Notice
S127 2017-08-07 30-day Notice
S126 2017-06-28 30-day Notice
S125 2017-06-23 30-day Notice
S124 2017-06-07 30-day Notice
S123 2017-01-17 30-day Notice
S122 2016-11-28 30-day Notice
S121 2016-11-14 30-day Notice
S120 2016-10-05 30-day Notice
S119 2016-09-02 30-day Notice
S118 2016-06-24 30-day Notice
S117 2016-03-17 30-day Notice
S116 2015-12-28 30-day Notice
S115 2015-12-22 30-day Notice
S114 2015-04-17 30-day Notice
S113 2015-02-09 30-day Notice
S112 2014-09-29 30-day Notice
S111 2014-08-27 30-day Notice
S110 2014-08-08 30-day Notice
S109 2014-07-24 30-day Notice
S108 2014-07-14 30-day Notice
S107 2014-02-27 30-day Notice
S106 2014-01-29 30-day Notice
S105 2013-12-24 30-day Notice
S104 2013-12-19 30-day Notice
S103 2013-10-30 30-day Notice
S102 2013-10-24 30-day Notice
S101 2013-09-30 30-day Notice
S100 2013-09-17 30-day Notice
S099 2013-05-21 30-day Notice
S098 2013-05-17 Real-time Process
S097 2013-04-30 30-day Notice
S096
S095 2013-04-10 Normal 180 Day Track No User Fee
S094 2013-03-22 30-day Notice
S093 2013-03-20 30-day Notice
S092 2012-12-10 30-day Notice
S091 2012-11-21 30-day Notice
S090 2012-09-28 30-day Notice
S089 2012-08-03 30-day Notice
S088 2012-06-11 30-day Notice
S087 2012-02-29 30-day Notice
S086 2011-11-25 30-day Notice
S085 2011-11-21 Normal 180 Day Track
S084 2011-10-24 135 Review Track For 30-day Notice
S083 2011-07-18 30-day Notice
S082 2011-07-08 30-day Notice
S081 2011-06-28 30-day Notice
S080 2011-06-27 30-day Notice
S079 2011-06-08 30-day Notice
S078 2011-06-08 135 Review Track For 30-day Notice
S077 2011-05-13 30-day Notice
S076 2011-04-26 30-day Notice
S075 2011-03-22 135 Review Track For 30-day Notice
S074 2011-03-18 135 Review Track For 30-day Notice
S073 2011-02-28 30-day Notice
S072 2010-11-12 30-day Notice
S071 2010-10-26 30-day Notice
S070 2010-09-29 30-day Notice
S069 2010-07-15 30-day Notice
S068 2010-07-15 30-day Notice
S067 2010-07-15 30-day Notice
S066 2010-06-28 135 Review Track For 30-day Notice
S065 2010-03-29 30-day Notice
S064 2010-01-19 30-day Notice
S063 2010-01-15 Real-time Process
S062 2009-10-08 Real-time Process
S061 2009-02-05 30-day Notice
S060 2008-12-11 30-day Notice
S059
S058 2008-03-24 30-day Notice
S057 2008-03-10 135 Review Track For 30-day Notice
S056 2007-06-27 30-day Notice
S055 2007-05-18 30-day Notice
S054 2006-05-10 135 Review Track For 30-day Notice
S053 2004-03-01 135 Review Track For 30-day Notice
S052 2003-03-04 30-day Notice
S051 2002-12-24 Real-time Process
S050 2001-11-14 Real-time Process
S049 2001-11-05 Special (immediate Track)
S048
S047 2001-07-17 30-day Notice
S046 2001-05-21 Real-time Process
S045 2000-12-07 Real-time Process
S044 2000-01-11 30-day Notice
S043 2000-01-05 30-day Notice
S042 1999-07-09 Real-time Process
S041 1999-05-03 Special (immediate Track)
S040 1998-10-01 Real-time Process
S039 1998-04-20
S038 1997-11-03 Normal 180 Day Track
S037 1997-10-10 Real-time Process
S036 1996-11-20 Normal 180 Day Track
S035 1996-05-08 Normal 180 Day Track
S034 1996-05-02 Normal 180 Day Track
S033 1995-04-06 Normal 180 Day Track
S032 1995-01-30 Normal 180 Day Track
S031 1994-09-08 Normal 180 Day Track
S030 1994-08-08 Normal 180 Day Track
S029 1994-06-01 Normal 180 Day Track
S028 1993-08-06 Normal 180 Day Track
S027 1993-03-29 Normal 180 Day Track
S026 1992-12-24 Normal 180 Day Track
S025
S024 1992-06-15 Normal 180 Day Track
S023 1992-03-30 Normal 180 Day Track
S022
S021
S020 1992-01-27 Special (immediate Track)
S019
S018 1991-10-03 Normal 180 Day Track
S017 1991-07-29 Normal 180 Day Track
S016 1991-05-16 Normal 180 Day Track
S015 1990-08-20 Normal 180 Day Track
S014 1990-05-15 Normal 180 Day Track
S013 1990-04-18 Normal 180 Day Track
S012 1990-03-12 Normal 180 Day Track
S011 1989-03-02 Normal 180 Day Track
S010 1989-02-23 Normal 180 Day Track
S009 1988-01-03 Normal 180 Day Track
S008 1988-10-21 Normal 180 Day Track
S007 1988-03-08 Normal 180 Day Track
S006 1988-02-25 Normal 180 Day Track
S005 1987-07-08 Normal 180 Day Track
S004 1987-06-23 Normal 180 Day Track
S003 1986-09-25 Normal 180 Day Track
S002 1986-09-11 Normal 180 Day Track
S001 1986-08-28 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
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00763000059170 P850089 038
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00613994560391 P850089 038
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00613994560384 P850089 038
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00613994250230 P850089 040
00613994250230 P850089 040
00681490135108 P850089 045
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00681490123228 P850089 045
00643169590731 P850089 110
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00643169590731 P850089 110
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00643169590731 P850089 110
00643169590731 P850089 110
00643169590731 P850089 110
00643169590731 P850089 110
00643169590731 P850089 110
00643169590731 P850089 110
00643169590731 P850089 110
00643169590731 P850089 110
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00643169590731 P850089 110
00643169590687 P850089 110
00643169590694 P850089 110
00643169590700 P850089 110
00643169590687 P850089 110
00643169590694 P850089 110
00643169590700 P850089 110
00643169590724 P850089 110
00643169590731 P850089 110
00643169590748 P850089 110
00643169590755 P850089 110
00643169590762 P850089 110
00643169638747 P850089 110
00643169638785 P850089 110
00643169590670 P850089 110
00643169590663 P850089 110
00643169590724 P850089 110
00643169590731 P850089 110
00643169590748 P850089 110
00643169590755 P850089 110
00643169590762 P850089 110
00643169638730 P850089 110
00643169638747 P850089 110
00643169638785 P850089 110
00643169638792 P850089 110
00643169638730 P850089 110
00643169638792 P850089 110

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