Approval for quadra assura mp cardiac resynchronization therapy devices (crt-ds) models cd3269-40, cd3269-40q, cd3369-40, cd3369-40q, cd3369-40c, cd3369- 40qc; quadra allure mp cardiac resynchronization therapy pacemaker devices (crt-ps) models pm3160 and pm3262; and model 3330 version 21. 1 software for the model 3650 merlin patient care system programmer.
| Device | MICRONY FAMILY OF PACEMAKERS |
| Generic Name | Defibrillator, Automatic Implantable Cardioverter, With Cardiac Resynchronization (crt-d) |
| Applicant | St. Jude Medical, Inc. |
| Date Received | 2015-08-17 |
| Decision Date | 2016-02-12 |
| PMA | P970013 |
| Supplement | S066 |
| Product Code | NIK |
| 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, Inc. 15900 Valley View Court sylmar, CA 91342 |
Supplemental Filings
| Supplement Number | Date | Supplement Type |
|---|
| P970013 | | Original Filing |
| S091 |
2022-07-27 |
Real-time Process |
| S090 |
2022-03-07 |
Real-time Process |
| S089 |
2021-10-18 |
Real-time Process |
| S088 |
2021-06-28 |
30-day Notice |
| S087 |
2021-04-02 |
Real-time Process |
| S086 |
2021-03-12 |
30-day Notice |
| S085 | | |
| S084 |
2020-10-21 |
30-day Notice |
| S083 |
2020-02-13 |
30-day Notice |
| S082 | | |
| S081 |
2019-10-30 |
Real-time Process |
| S080 |
2018-11-20 |
30-day Notice |
| S079 |
2018-09-28 |
30-day Notice |
| S078 |
2018-07-17 |
30-day Notice |
| S077 |
2018-01-31 |
30-day Notice |
| S076 |
2018-01-18 |
Normal 180 Day Track |
| S075 |
2017-10-30 |
Real-time Process |
| S074 |
2017-10-10 |
30-day Notice |
| S073 |
2017-09-21 |
30-day Notice |
| S072 |
2017-08-16 |
30-day Notice |
| S071 |
2017-05-17 |
Normal 180 Day Track |
| S070 |
2017-02-07 |
Real-time Process |
| S069 |
2016-04-04 |
Real-time Process |
| S068 | | |
| S067 |
2015-10-26 |
135 Review Track For 30-day Notice |
| S066 |
2015-08-17 |
Normal 180 Day Track |
| S065 |
2015-08-10 |
30-day Notice |
| S064 |
2015-02-11 |
Normal 180 Day Track |
| S063 |
2014-12-18 |
Real-time Process |
| S062 | | |
| S061 | | |
| S060 |
2014-07-02 |
Normal 180 Day Track |
| S059 |
2014-05-28 |
30-day Notice |
| S058 |
2014-04-15 |
Real-time Process |
| S057 |
2013-11-21 |
Normal 180 Day Track |
| S056 |
2013-04-15 |
30-day Notice |
| S055 |
2012-12-05 |
Normal 180 Day Track |
| S054 |
2012-11-14 |
Normal 180 Day Track |
| S053 | | |
| S052 |
2012-09-13 |
30-day Notice |
| S051 |
2012-08-16 |
Real-time Process |
| S050 |
2012-07-11 |
Normal 180 Day Track |
| S049 |
2012-05-30 |
Real-time Process |
| S048 |
2012-04-03 |
30-day Notice |
| S047 |
2012-02-29 |
Real-time Process |
| S046 | | |
| S045 |
2011-11-30 |
135 Review Track For 30-day Notice |
| S044 |
2011-11-01 |
Normal 180 Day Track |
| S043 |
2011-08-31 |
Real-time Process |
| S042 |
2011-08-08 |
Real-time Process |
| S041 |
2011-06-28 |
Real-time Process |
| S040 |
2011-05-02 |
Normal 180 Day Track |
| S039 |
2011-02-28 |
30-day Notice |
| S038 |
2010-11-23 |
Normal 180 Day Track |
| S037 |
2010-10-12 |
30-day Notice |
| S036 |
2010-08-16 |
Normal 180 Day Track No User Fee |
| S035 |
2010-07-30 |
Real-time Process |
| S034 |
2010-06-04 |
Normal 180 Day Track |
| S033 |
2010-05-21 |
30-day Notice |
| S032 |
2009-10-02 |
135 Review Track For 30-day Notice |
| S031 |
2009-09-14 |
Real-time Process |
| S030 |
2009-06-18 |
30-day Notice |
| S029 |
2009-06-10 |
30-day Notice |
| S028 |
2008-12-31 |
Real-time Process |
| S027 |
2008-07-30 |
Real-time Process |
| S026 |
2008-06-13 |
30-day Notice |
| S025 |
2008-06-02 |
Real-time Process |
| S024 |
2008-05-21 |
30-day Notice |
| S023 |
2008-03-25 |
Real-time Process |
| S022 |
2007-10-24 |
Real-time Process |
| S021 |
2007-10-19 |
Normal 180 Day Track No User Fee |
| S020 |
2007-09-21 |
Real-time Process |
| S019 |
2007-04-23 |
Normal 180 Day Track |
| S018 |
2007-04-13 |
Real-time Process |
| S017 |
2007-04-06 |
Real-time Process |
| S016 |
2006-12-22 |
135 Review Track For 30-day Notice |
| S015 |
2006-12-20 |
135 Review Track For 30-day Notice |
| S014 |
2006-10-20 |
Real-time Process |
| S013 |
2006-10-06 |
Real-time Process |
| S012 |
2006-09-27 |
30-day Notice |
| S011 |
2006-07-13 |
30-day Notice |
| S010 |
2006-06-07 |
Real-time Process |
| S009 | | |
| S008 |
2006-03-30 |
Real-time Process |
| S007 |
2006-03-07 |
Real-time Process |
| S006 |
2006-02-17 |
Normal 180 Day Track |
| S005 |
2006-02-03 |
Real-time Process |
| S004 |
2006-01-25 |
Normal 180 Day Track |
| S003 |
2006-01-06 |
Real-time Process |
| S002 |
2001-09-28 |
30-day Notice |
| S001 |
2001-03-13 |
Normal 180 Day Track |
NIH GUDID Devices