OptiSense Steroid Eluting Cardiac Lead

FDA Premarket Approval P960013 S112

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

Process improvements and changes associated with the optimized drug release/elution test method for batch release and annual stability for optisense leads mcrd component manufacturing

DeviceOptiSense Steroid Eluting Cardiac Lead
Generic NameDrug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes
ApplicantSt Jude Medical
Date Received2020-05-18
Decision Date2020-06-17
PMAP960013
SupplementS112
Product CodeNVN 
Advisory CommitteeCardiovascular
Supplement Type30-day Notice
Supplement ReasonProcess Change - Manufacturer/sterilizer/packager/supplier
Expedited ReviewNo
Combination Product Yes
Applicant Address St Jude Medical 15900 Valley View Ct. p.o. Box 9221 sylmar, CA 91392-9221

Supplemental Filings

Supplement NumberDateSupplement Type
P960013Original Filing
S113 2020-05-22 30-day Notice
S112 2020-05-18 30-day Notice
S111 2020-02-27 30-day Notice
S110 2019-11-18 30-day Notice
S109 2019-09-26 30-day Notice
S108 2019-07-30 135 Review Track For 30-day Notice
S107
S106 2018-11-30 30-day Notice
S105 2018-11-23 30-day Notice
S104 2018-11-20 30-day Notice
S103 2018-10-02 30-day Notice
S102 2018-10-01 30-day Notice
S101 2018-09-28 30-day Notice
S100 2018-07-02 30-day Notice
S099 2018-06-28 Normal 180 Day Track
S098 2018-06-20 Normal 180 Day Track
S097 2018-03-05 30-day Notice
S096 2018-02-27 30-day Notice
S095 2018-01-31 30-day Notice
S094 2018-01-26 30-day Notice
S093 2017-11-29 30-day Notice
S092 2017-02-28 30-day Notice
S091 2017-02-24 30-day Notice
S090 2017-02-17 135 Review Track For 30-day Notice
S089 2017-02-10 30-day Notice
S088 2017-01-25 30-day Notice
S087 2016-12-13 30-day Notice
S086 2016-10-12 30-day Notice
S085 2016-09-27 135 Review Track For 30-day Notice
S084
S083 2016-06-30 Real-time Process
S082 2016-06-22 30-day Notice
S081 2016-04-12 30-day Notice
S080 2016-04-04 30-day Notice
S079 2016-01-19 30-day Notice
S078 2015-10-26 135 Review Track For 30-day Notice
S077 2015-08-10 30-day Notice
S076 2013-09-05 30-day Notice
S075 2013-05-02 30-day Notice
S074 2012-09-13 30-day Notice
S073
S072 2012-04-03 30-day Notice
S071 2012-02-14 Real-time Process
S070 2012-01-31 30-day Notice
S069 2011-11-30 135 Review Track For 30-day Notice
S068 2011-11-07 Normal 180 Day Track
S067 2011-09-06 30-day Notice
S066 2011-07-22 Normal 180 Day Track
S065 2011-05-18 Normal 180 Day Track No User Fee
S064 2011-03-10 30-day Notice
S063 2010-12-13 135 Review Track For 30-day Notice
S062 2010-08-16 Normal 180 Day Track No User Fee
S061 2010-05-20 Normal 180 Day Track
S060 2010-05-13 30-day Notice
S059 2010-04-13 30-day Notice
S058 2010-03-23 Real-time Process
S057 2010-03-12 Normal 180 Day Track
S056 2009-12-24 30-day Notice
S055 2009-11-25 Normal 180 Day Track No User Fee
S054 2009-11-09 Normal 180 Day Track
S053 2009-10-23 30-day Notice
S052 2009-08-31 135 Review Track For 30-day Notice
S051 2009-08-28 30-day Notice
S050 2009-08-25 30-day Notice
S049 2009-08-19 30-day Notice
S048 2009-08-04 30-day Notice
S047 2009-06-10 30-day Notice
S046 2009-03-31 Real-time Process
S045 2009-03-19 Special (immediate Track)
S044 2009-02-25 135 Review Track For 30-day Notice
S043 2009-02-04 135 Review Track For 30-day Notice
S042 2009-01-30 30-day Notice
S041 2008-12-09 30-day Notice
S040 2008-05-21 30-day Notice
S039 2008-04-24 30-day Notice
S038 2008-05-01 Normal 180 Day Track
S037 2008-02-01 Normal 180 Day Track No User Fee
S036 2007-11-19 30-day Notice
S035 2007-10-19 Normal 180 Day Track No User Fee
S034 2007-09-28 30-day Notice
S033 2007-05-11 Real-time Process
S032 2007-05-10 30-day Notice
S031 2007-05-09 30-day Notice
S030 2007-03-26 135 Review Track For 30-day Notice
S029 2007-03-19 135 Review Track For 30-day Notice
S028 2007-02-26 135 Review Track For 30-day Notice
S027 2007-02-21 30-day Notice
S026
S025 2006-11-30 Normal 180 Day Track
S024 2006-11-21 30-day Notice
S023 2006-09-29 Real-time Process
S022 2006-08-17 Real-time Process
S021 2006-07-03 30-day Notice
S020 2006-05-31 30-day Notice
S019 2006-05-15 30-day Notice
S018 2006-04-13 Real-time Process
S017 2006-02-22 30-day Notice
S016 2006-02-06 30-day Notice
S015 2005-12-08 Real-time Process
S014 2005-10-24 135 Review Track For 30-day Notice
S013 2003-04-23 Real-time Process
S012 2002-12-04 Real-time Process
S011 2002-11-22 Real-time Process
S010 2002-03-06 Real-time Process
S009 2000-11-16 Real-time Process
S008 2000-08-11 Normal 180 Day Track
S007 1999-09-13 Normal 180 Day Track
S006 1999-07-02 135 Review Track For 30-day Notice
S005 1999-03-04 Special (immediate Track)
S004 1998-09-15 30-day Notice
S003
S002 1997-12-12 Normal 180 Day Track
S001 1997-09-24 Normal 180 Day Track

NIH GUDID Devices

Device IDPMASupp
05414734005715 P960013 013
05414734501996 P960013 013
05414734501859 P960013 013
05414734501989 P960013 013
05414734504812 P960013 013
05414734005777 P960013 013
05414734501705 P960013 018
05414734501699 P960013 018
05414734501750 P960013 018
05414734501774 P960013 018
05414734501743 P960013 018
05414734501231 P960013 022
05414734501101 P960013 022
05414734501118 P960013 022
05414734501125 P960013 022
05414734501224 P960013 022
05414734501248 P960013 022
05414734502467 P960013 038
05414734502481 P960013 038
05414734502474 P960013 038
05414734502894 P960013 046
05414734502887 P960013 046
05414734502870 P960013 046
05414734505031 P960013 046
05414734505055 P960013 046

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