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 NumberS076 Date Received07/14/2022 Decision Date08/01/2022 Product Code NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-07-14 |
| Decision Date | 2022-08-01 |
| PMA | P960030 |
| Supplement | S076 |
| Product Code | NVN |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Abbott Medical 15900 Valley View Court sylmar, CA 91335 PMA NumberP960030 Supplement NumberS076 Date Received07/14/2022 Decision Date08/01/2022 Product Code NVN Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement implementation Of The Automated System Vaisala EMS System For Environmental And Process Equipment Monitoring At The Rogers, Minnesota Manufacturing Site |
| 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 |