Approval for distal tip changes to the tendril st model 1888 lead family. The device, as modified, will be marketed under the trade name tendril sts model 2088tc, and are transvenous steroid eluting leads indicated for use in the right atrium or right ventricle, in combination with a compatible pulse generator.
| Device | TENDRIL STS LEAD MODEL 2088TC |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | St Jude Medical |
| Date Received | 2009-03-31 |
| Decision Date | 2009-05-26 |
| PMA | P960013 |
| Supplement | S046 |
| Product Code | NVN |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | Yes |
| 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