Approval for device modifications to the isoflex optim family of leads. The devices, as modified, will be marketed under the trade names isoflex optim model 1944t and isoflex optim 1948t.
| Device | ISOFLEX OPTIM LEADS |
| Classification Name | Permanent Defibrillator Electrodes |
| Generic Name | Permanent Defibrillator Electrodes |
| Applicant | St. Jude Medical |
| Date Received | 2008-01-17 |
| Decision Date | 2008-03-18 |
| PMA | P960030 |
| Supplement | S020 |
| Product Code | NVY |
| 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 |
|---|
| P960030 | | Original Filing |
| S077 |
2022-09-08 |
Real-time Process |
| S076 |
2022-07-14 |
30-day Notice |
| S075 |
2021-06-28 |
30-day Notice |
| S074 |
2021-03-12 |
30-day Notice |
| S073 |
2021-02-19 |
30-day Notice |
| S072 |
2020-11-25 |
30-day Notice |
| S071 |
2020-10-21 |
30-day Notice |
| S070 |
2020-08-11 |
Real-time Process |
| S069 |
2020-05-22 |
30-day Notice |
| S068 |
2020-02-27 |
30-day Notice |
| S067 |
2019-09-26 |
30-day Notice |
| S066 | | |
| S065 |
2018-11-30 |
30-day Notice |
| S064 |
2018-11-23 |
30-day Notice |
| S063 |
2018-11-20 |
30-day Notice |
| S062 |
2018-10-02 |
30-day Notice |
| S061 |
2018-10-01 |
30-day Notice |
| S060 |
2018-09-28 |
30-day Notice |
| S059 |
2018-07-02 |
30-day Notice |
| S058 |
2018-03-05 |
30-day Notice |
| S057 |
2018-02-27 |
30-day Notice |
| S056 |
2018-01-31 |
30-day Notice |
| S055 |
2018-01-26 |
30-day Notice |
| S054 |
2017-02-28 |
30-day Notice |
| S053 |
2017-02-24 |
30-day Notice |
| S052 |
2017-02-17 |
135 Review Track For 30-day Notice |
| S051 |
2017-02-10 |
30-day Notice |
| S050 |
2017-01-25 |
30-day Notice |
| S049 |
2016-12-13 |
30-day Notice |
| S048 |
2016-10-12 |
30-day Notice |
| S047 |
2016-09-27 |
135 Review Track For 30-day Notice |
| S046 | | |
| S045 |
2016-06-22 |
30-day Notice |
| S044 |
2016-04-12 |
30-day Notice |
| S043 |
2016-04-04 |
30-day Notice |
| S042 |
2016-01-21 |
30-day Notice |
| S041 |
2016-01-19 |
30-day Notice |
| S040 |
2015-10-26 |
135 Review Track For 30-day Notice |
| S039 |
2015-08-10 |
30-day Notice |
| S038 |
2013-09-05 |
30-day Notice |
| S037 |
2012-09-13 |
30-day Notice |
| S036 |
2012-04-03 |
30-day Notice |
| S035 |
2012-02-14 |
Real-time Process |
| S034 |
2011-11-30 |
135 Review Track For 30-day Notice |
| S033 |
2011-04-04 |
30-day Notice |
| S032 |
2010-08-16 |
Normal 180 Day Track No User Fee |
| S031 |
2010-05-20 |
Normal 180 Day Track |
| S030 |
2010-04-13 |
30-day Notice |
| S029 |
2009-12-24 |
30-day Notice |
| S028 |
2009-11-25 |
Normal 180 Day Track No User Fee |
| S027 |
2009-08-28 |
30-day Notice |
| S026 |
2009-06-10 |
30-day Notice |
| S025 |
2009-01-30 |
30-day Notice |
| S024 |
2008-10-29 |
30-day Notice |
| S023 |
2008-08-26 |
Normal 180 Day Track No User Fee |
| S022 |
2008-05-21 |
30-day Notice |
| S021 |
2008-02-01 |
Normal 180 Day Track No User Fee |
| S020 |
2008-01-17 |
Real-time Process |
| S019 |
2007-10-19 |
Normal 180 Day Track No User Fee |
| S018 |
2007-09-28 |
30-day Notice |
| S017 |
2007-09-24 |
30-day Notice |
| S016 |
2007-03-05 |
Real-time Process |
| S015 |
2007-02-26 |
135 Review Track For 30-day Notice |
| S014 |
2007-02-08 |
30-day Notice |
| S013 |
2005-09-09 |
Real-time Process |
| S012 |
2004-08-03 |
Normal 180 Day Track |
| S011 |
2004-07-16 |
Normal 180 Day Track No User Fee |
| S010 |
2003-02-11 |
Real-time Process |
| S009 |
2002-12-04 |
Real-time Process |
| S008 |
2000-11-16 |
Real-time Process |
| S007 |
2000-08-11 |
Normal 180 Day Track |
| S006 |
1999-07-02 |
135 Review Track For 30-day Notice |
| S005 |
1999-04-01 |
Normal 180 Day Track |
| S004 |
1998-09-16 |
30-day Notice |
| S003 |
1998-09-15 |
30-day Notice |
| S002 | | |
| S001 | | |
NIH GUDID Devices