Changes to acceptance criteria for impurities.
| Device | Tendril SDX/ST/STS and optisense leads (LV active) |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | St Jude Medical |
| Date Received | 2017-02-24 |
| Decision Date | 2017-03-21 |
| PMA | P960013 |
| Supplement | S091 |
| Product Code | NVN |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| 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