SelectSecure Lead

FDA Premarket Approval P030036 S118

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 transfer two incoming inspection activities for device components from medtronic rice creek to medtronic puerto rico operations company villalba/juncos sites

DeviceSelectSecure Lead
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantMEDTRONIC CARDIAC RHYTHM DISEASE MANAGEMENT
Date Received2020-02-20
Decision Date2020-03-06
PMAP030036
SupplementS118
Product CodeNVN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
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
P030036Original Filing
S118 2020-02-20 30-day Notice
S117 2020-01-17 30-day Notice
S116 2019-12-17 30-day Notice
S115 2019-11-18 30-day Notice
S114
S113 2019-08-22 30-day Notice
S112 2019-07-01 30-day Notice
S111
S110 2019-06-10 30-day Notice
S109 2019-05-06 30-day Notice
S108 2019-02-28 30-day Notice
S107 2018-11-02 30-day Notice
S106
S105 2018-10-23 30-day Notice
S104 2018-10-18 30-day Notice
S103 2018-09-26 30-day Notice
S102 2018-06-01 30-day Notice
S101 2018-05-15 30-day Notice
S100 2018-04-13 Normal 180 Day Track
S099 2018-02-22 30-day Notice
S098 2017-12-04 Real-time Process
S097 2017-11-20 30-day Notice
S096 2017-08-07 30-day Notice
S095 2017-05-18 Normal 180 Day Track
S094 2017-04-03 Normal 180 Day Track
S093 2017-01-25 Real-time Process
S092 2016-12-06 Normal 180 Day Track
S091 2016-12-06 Normal 180 Day Track
S090 2016-11-28 30-day Notice
S089 2016-11-14 30-day Notice
S088 2016-11-02 Normal 180 Day Track
S087 2016-10-05 30-day Notice
S086 2016-07-18 30-day Notice
S085 2016-06-24 30-day Notice
S084 2015-12-28 30-day Notice
S083 2015-12-28 30-day Notice
S082 2015-12-23 Normal 180 Day Track
S081 2015-12-22 30-day Notice
S080 2015-10-23 30-day Notice
S079 2015-07-20 30-day Notice
S078 2015-04-17 30-day Notice
S077 2015-02-09 30-day Notice
S076 2015-01-21 30-day Notice
S075
S074 2014-08-27 30-day Notice
S073 2014-08-08 30-day Notice
S072 2014-07-24 30-day Notice
S071 2014-02-27 30-day Notice
S070 2014-01-29 30-day Notice
S069 2013-12-24 30-day Notice
S068 2013-12-19 30-day Notice
S067 2013-11-22 30-day Notice
S066 2013-10-30 30-day Notice
S065 2013-10-24 30-day Notice
S064 2013-09-30 30-day Notice
S063 2013-09-26 30-day Notice
S062 2013-09-17 30-day Notice
S061 2013-09-13 30-day Notice
S060
S059 2013-05-21 30-day Notice
S058 2013-05-17 Real-time Process
S057 2013-04-30 30-day Notice
S056 2013-04-10 Normal 180 Day Track No User Fee
S055 2013-03-22 30-day Notice
S054 2013-03-20 30-day Notice
S053 2013-02-01 Special (immediate Track)
S052 2012-11-21 30-day Notice
S051 2012-10-26 Real-time Process
S050 2012-10-22 30-day Notice
S049 2012-09-28 30-day Notice
S048 2012-09-21 30-day Notice
S047 2012-09-04 30-day Notice
S046 2012-08-03 30-day Notice
S045 2012-07-13 30-day Notice
S044 2012-06-20 30-day Notice
S043 2012-06-11 30-day Notice
S042 2012-03-09 30-day Notice
S041 2012-02-29 30-day Notice
S040 2012-02-06 Normal 180 Day Track No User Fee
S039 2011-12-09 135 Review Track For 30-day Notice
S038 2011-11-25 30-day Notice
S037 2011-11-21 Normal 180 Day Track
S036 2011-07-18 30-day Notice
S035 2011-07-08 30-day Notice
S034 2011-06-28 30-day Notice
S033 2011-06-08 30-day Notice
S032 2011-06-08 135 Review Track For 30-day Notice
S031
S030 2011-04-26 30-day Notice
S029 2011-04-22 30-day Notice
S028 2011-04-12 30-day Notice
S027 2011-03-22 135 Review Track For 30-day Notice
S026 2011-02-28 30-day Notice
S025 2010-11-12 30-day Notice
S024 2010-10-26 30-day Notice
S023
S022 2010-07-30 Normal 180 Day Track No User Fee
S021 2010-07-15 30-day Notice
S020 2010-07-15 30-day Notice
S019 2010-07-15 30-day Notice
S018 2010-06-28 135 Review Track For 30-day Notice
S017 2010-06-09 30-day Notice
S016 2010-03-29 30-day Notice
S015 2010-01-19 30-day Notice
S014 2010-01-15 Real-time Process
S013 2009-03-17 Real-time Process
S012 2009-02-05 30-day Notice
S011 2008-12-11 30-day Notice
S010 2008-11-03 30-day Notice
S009 2008-08-22 135 Review Track For 30-day Notice
S008 2008-07-31 30-day Notice
S007 2008-06-17 30-day Notice
S006 2008-04-14 30-day Notice
S005 2008-03-24 30-day Notice
S004 2007-12-31 Normal 180 Day Track
S003 2007-02-26 135 Review Track For 30-day Notice
S002 2006-09-07 Special (immediate Track)
S001 2006-05-10 135 Review Track For 30-day Notice

NIH GUDID Devices

Device IDPMASupp
00885074406428 P030036 000
00613994520784 P030036 000
00613994119957 P030036 000
00885074407968 P030036 000
00885074406428 P030036 000
00885074407968 P030036 000
00613994119957 P030036 000
00613994520784 P030036 000
00613994567611 P030036 013
00613994567611 P030036 013
00613994726117 P030036 022
00613994726117 P030036 022
00643169279209 P030036 040
00643169279292 P030036 040
00643169279209 P030036 040
00643169279193 P030036 040
00643169279292 P030036 040
00643169279186 P030036 040
00643169279186 P030036 040
00643169279193 P030036 040
00643169535848 P030036 073
00643169535855 P030036 073
00643169535879 P030036 073
00643169535886 P030036 073
00643169535848 P030036 073
00643169535855 P030036 073
00643169535879 P030036 073
00643169535886 P030036 073
00643169857674 P030036 088
00643169857681 P030036 088
00643169857698 P030036 088
00643169857698 P030036 088
00643169857681 P030036 088
00643169857674 P030036 088
00763000130817 P030036 100
00763000130800 P030036 100
00763000130794 P030036 100
00763000130817 P030036 100
00763000130800 P030036 100
00763000130794 P030036 100

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