Approval for the tendril st lead models 1788t/tc and 1782 tc. The devices, as modified, will be marketed under the trade names tendril st model 1788 t, tendril st model 1788tc, and tendril st model 1782tc. The tendril st model 1788 lead is designed for permanent sensing in either the right atrium or the right ventricle, in combination with a compatible pulse generator. The tendril st model 1782 lead is designed for permanent sensing and pacing in the right atrium, in combination with a compatible pulse generator.
| Device | TENDRIL ST LEAD MODELS 1788T/TC AND 1782 TC |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | St Jude Medical |
| Date Received | 2005-12-08 |
| Decision Date | 2006-02-07 |
| PMA | P960013 |
| Supplement | S015 |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | St Jude Medical 15900 Valley View Ct. p.o. Box 9221 sylmar, CA 91392-9221 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P960013 | | Original Filing |
| S121 |
2022-07-14 |
30-day Notice |
| S120 |
2021-08-02 |
30-day Notice |
| S119 |
2021-06-28 |
30-day Notice |
| S118 | | |
| S117 |
2021-03-12 |
30-day Notice |
| S116 |
2020-11-25 |
30-day Notice |
| S115 |
2020-10-21 |
30-day Notice |
| S114 | | |
| 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