Approval for the optisense model 1699t and 1699tc leads. The device, as modified, will be marketed under the trade name optisense model 1699t and 1699tc leads and are designed for permanent sensing and pacing in the right atrium, in combination with a compatible pulse generator. An active fixation lead such as the model 1699 may be indicated for patients where permanent fixation of passive leads is suspected to be unstable. In atrial applications, the use of a screw-in lead may be indicated in the presence of an abnormal, surgically altered or excised atrial appendage.
| Device | OPTISENSE MODEL 1699T/TC LEADS |
| Classification Name | Pulse Generator, Permanent, Implantable |
| Generic Name | Pulse Generator, Permanent, Implantable |
| Applicant | St Jude Medical |
| Date Received | 2006-11-30 |
| Decision Date | 2007-05-07 |
| PMA | P960013 |
| Supplement | S025 |
| Product Code | NVZ |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| 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