Approval for mcrd and steroid coating test methodologies, specifications, stability protocols and other manufacturing processes to meet the requirements in the agreed upon steroid commitment letter. Approval for mcrd and steroid coating test methodologies, specifications, stability protocols and other manufacturing processes to meet the requirements in the agreed upon steroid commitment letter.
| Device | TENDRIL, TENDRIL ST, TENDRIL STS, AND OPTISENSE LEADS |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | St Jude Medical |
| Date Received | 2010-05-20 |
| Decision Date | 2015-08-13 |
| PMA | P960013 |
| Supplement | S061 |
| Product Code | NVN |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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