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 | IsoFlex |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP960030 Supplement NumberS077 Date Received09/08/2022 Decision Date12/07/2022 Product Code NVN Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No |
| Date Received | 2022-09-08 |
| Decision Date | 2022-12-07 |
| PMA | P960030 |
| Supplement | S077 |
| Product Code | NVN |
| 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 NumberP960030 Supplement NumberS077 Date Received09/08/2022 Decision Date12/07/2022 Product Code NVN Advisory Committee Cardiovascular Supplement Typereal-time Process Supplement Reason Change Design/components/specifications/material Expedited Review Granted? No Combination ProductNo Approval Order Statement Approval For MR Conditional Labeling For IsoFlex Pacing Leads When Combined With The Assurity MRI And Endurity MRI Single And Dual Chamber Implantable Pulse Generators. |
| 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 |
| Device ID | PMA | Supp |
|---|---|---|
| 05414734502351 | P960030 | 020 |
| 05414734502344 | P960030 | 020 |
| 05414734502337 | P960030 | 020 |
| 05414734502320 | P960030 | 020 |
| 05414734502313 | P960030 | 020 |