This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
| Device | Microny family of Pacemakers |
| Generic Name | Pulse-generator, Single Chamber, Sensor Driven, Implantable |
| Applicant | Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP970013 Supplement NumberS091 Date Received07/27/2022 Decision Date09/30/2022 Product Code LWO Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-07-27 |
| Decision Date | 2022-09-30 |
| PMA | P970013 |
| Supplement | S091 |
| Product Code | LWO |
| Advisory Committee | Cardiovascular |
| Supplement Type | Real-time Process |
| Supplement Reason | Change Design/components/specifications/material |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 15900 Valley View Court sylmar, CA 91335 PMA NumberP970013 Supplement NumberS091 Date Received07/27/2022 Decision Date09/30/2022 Product Code LWO Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 05414734006224 | P970013 | 036 |