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 | OptiSense, Tendril STS, Tendril SDX, Tendril ST |
| Generic Name | Drug Eluting Permanent Right Ventricular (rv) Or Right Atrial (ra) Pacemaker Electrodes |
| Applicant | Abbott Medical15900 Valley View Courtsylmar, CA 91335 PMA NumberP960013 Supplement NumberS121 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 | P960013 |
| Supplement | S121 |
| Product Code | NVN |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | Abbott Medical 15900 Valley View Court sylmar, CA 91335 PMA NumberP960013 Supplement NumberS121 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 ProductYes 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 |
|---|---|---|
| P960013 | Original Filing | |
| S121 | 2022-07-14 | 30-day Notice |
| S120 | 2021-08-02 | 30-day Notice |
| S119 | 2021-06-28 | 30-day Notice |
| S118 | ||
| S117 | 2021-03-12 | 30-day Notice |
| S116 | 2020-11-25 | 30-day Notice |
| S115 | 2020-10-21 | 30-day Notice |
| S114 | ||
| S113 | 2020-05-22 | 30-day Notice |
| S112 | 2020-05-18 | 30-day Notice |
| S111 | 2020-02-27 | 30-day Notice |
| S110 | 2019-11-18 | 30-day Notice |
| S109 | 2019-09-26 | 30-day Notice |
| S108 | 2019-07-30 | 135 Review Track For 30-day Notice |
| S107 | ||
| S106 | 2018-11-30 | 30-day Notice |
| S105 | 2018-11-23 | 30-day Notice |
| S104 | 2018-11-20 | 30-day Notice |
| S103 | 2018-10-02 | 30-day Notice |
| S102 | 2018-10-01 | 30-day Notice |
| S101 | 2018-09-28 | 30-day Notice |
| S100 | 2018-07-02 | 30-day Notice |
| S099 | 2018-06-28 | Normal 180 Day Track |
| S098 | 2018-06-20 | Normal 180 Day Track |
| S097 | 2018-03-05 | 30-day Notice |
| S096 | 2018-02-27 | 30-day Notice |
| S095 | 2018-01-31 | 30-day Notice |
| S094 | 2018-01-26 | 30-day Notice |
| S093 | 2017-11-29 | 30-day Notice |
| S092 | 2017-02-28 | 30-day Notice |
| S091 | 2017-02-24 | 30-day Notice |
| S090 | 2017-02-17 | 135 Review Track For 30-day Notice |
| S089 | 2017-02-10 | 30-day Notice |
| S088 | 2017-01-25 | 30-day Notice |
| S087 | 2016-12-13 | 30-day Notice |
| S086 | 2016-10-12 | 30-day Notice |
| S085 | 2016-09-27 | 135 Review Track For 30-day Notice |
| S084 | ||
| S083 | 2016-06-30 | Real-time Process |
| S082 | 2016-06-22 | 30-day Notice |
| S081 | 2016-04-12 | 30-day Notice |
| S080 | 2016-04-04 | 30-day Notice |
| S079 | 2016-01-19 | 30-day Notice |
| S078 | 2015-10-26 | 135 Review Track For 30-day Notice |
| S077 | 2015-08-10 | 30-day Notice |
| S076 | 2013-09-05 | 30-day Notice |
| S075 | 2013-05-02 | 30-day Notice |
| S074 | 2012-09-13 | 30-day Notice |
| S073 | ||
| S072 | 2012-04-03 | 30-day Notice |
| S071 | 2012-02-14 | Real-time Process |
| S070 | 2012-01-31 | 30-day Notice |
| S069 | 2011-11-30 | 135 Review Track For 30-day Notice |
| S068 | 2011-11-07 | Normal 180 Day Track |
| S067 | 2011-09-06 | 30-day Notice |
| S066 | 2011-07-22 | Normal 180 Day Track |
| S065 | 2011-05-18 | Normal 180 Day Track No User Fee |
| S064 | 2011-03-10 | 30-day Notice |
| S063 | 2010-12-13 | 135 Review Track For 30-day Notice |
| S062 | 2010-08-16 | Normal 180 Day Track No User Fee |
| S061 | 2010-05-20 | Normal 180 Day Track |
| S060 | 2010-05-13 | 30-day Notice |
| S059 | 2010-04-13 | 30-day Notice |
| S058 | 2010-03-23 | Real-time Process |
| S057 | 2010-03-12 | Normal 180 Day Track |
| S056 | 2009-12-24 | 30-day Notice |
| S055 | 2009-11-25 | Normal 180 Day Track No User Fee |
| S054 | 2009-11-09 | Normal 180 Day Track |
| S053 | 2009-10-23 | 30-day Notice |
| S052 | 2009-08-31 | 135 Review Track For 30-day Notice |
| S051 | 2009-08-28 | 30-day Notice |
| S050 | 2009-08-25 | 30-day Notice |
| S049 | 2009-08-19 | 30-day Notice |
| S048 | 2009-08-04 | 30-day Notice |
| S047 | 2009-06-10 | 30-day Notice |
| S046 | 2009-03-31 | Real-time Process |
| S045 | 2009-03-19 | Special (immediate Track) |
| S044 | 2009-02-25 | 135 Review Track For 30-day Notice |
| S043 | 2009-02-04 | 135 Review Track For 30-day Notice |
| S042 | 2009-01-30 | 30-day Notice |
| S041 | 2008-12-09 | 30-day Notice |
| S040 | 2008-05-21 | 30-day Notice |
| S039 | 2008-04-24 | 30-day Notice |
| S038 | 2008-05-01 | Normal 180 Day Track |
| S037 | 2008-02-01 | Normal 180 Day Track No User Fee |
| S036 | 2007-11-19 | 30-day Notice |
| S035 | 2007-10-19 | Normal 180 Day Track No User Fee |
| S034 | 2007-09-28 | 30-day Notice |
| S033 | 2007-05-11 | Real-time Process |
| S032 | 2007-05-10 | 30-day Notice |
| S031 | 2007-05-09 | 30-day Notice |
| S030 | 2007-03-26 | 135 Review Track For 30-day Notice |
| S029 | 2007-03-19 | 135 Review Track For 30-day Notice |
| S028 | 2007-02-26 | 135 Review Track For 30-day Notice |
| S027 | 2007-02-21 | 30-day Notice |
| S026 | ||
| S025 | 2006-11-30 | Normal 180 Day Track |
| S024 | 2006-11-21 | 30-day Notice |
| S023 | 2006-09-29 | Real-time Process |
| S022 | 2006-08-17 | Real-time Process |
| S021 | 2006-07-03 | 30-day Notice |
| S020 | 2006-05-31 | 30-day Notice |
| S019 | 2006-05-15 | 30-day Notice |
| S018 | 2006-04-13 | Real-time Process |
| S017 | 2006-02-22 | 30-day Notice |
| S016 | 2006-02-06 | 30-day Notice |
| S015 | 2005-12-08 | Real-time Process |
| S014 | 2005-10-24 | 135 Review Track For 30-day Notice |
| S013 | 2003-04-23 | Real-time Process |
| S012 | 2002-12-04 | Real-time Process |
| S011 | 2002-11-22 | Real-time Process |
| S010 | 2002-03-06 | Real-time Process |
| S009 | 2000-11-16 | Real-time Process |
| S008 | 2000-08-11 | Normal 180 Day Track |
| S007 | 1999-09-13 | Normal 180 Day Track |
| S006 | 1999-07-02 | 135 Review Track For 30-day Notice |
| S005 | 1999-03-04 | Special (immediate Track) |
| S004 | 1998-09-15 | 30-day Notice |
| S003 | ||
| S002 | 1997-12-12 | Normal 180 Day Track |
| S001 | 1997-09-24 | Normal 180 Day Track |
| Device ID | PMA | Supp |
|---|---|---|
| 05414734501989 | P960013 | 013 |
| 05414734501859 | P960013 | 013 |
| 05414734501996 | P960013 | 013 |
| 05414734005777 | P960013 | 013 |
| 05414734504812 | P960013 | 013 |
| 05414734005715 | P960013 | 013 |
| 05414734501699 | P960013 | 018 |
| 05414734501750 | P960013 | 018 |
| 05414734501774 | P960013 | 018 |
| 05414734501743 | P960013 | 018 |
| 05414734501705 | P960013 | 018 |
| 05414734501118 | P960013 | 022 |
| 05414734501125 | P960013 | 022 |
| 05414734501101 | P960013 | 022 |
| 05414734501248 | P960013 | 022 |
| 05414734501231 | P960013 | 022 |
| 05414734501224 | P960013 | 022 |
| 05414734502467 | P960013 | 038 |
| 05414734502474 | P960013 | 038 |
| 05414734502481 | P960013 | 038 |
| 05414734505055 | P960013 | 046 |
| 05414734502870 | P960013 | 046 |
| 05414734502887 | P960013 | 046 |
| 05414734502894 | P960013 | 046 |
| 05414734505031 | P960013 | 046 |
| 05415067037275 | P960013 | 118 |
| 05415067046345 | P960013 | 122 |
| 05415067046338 | P960013 | 122 |
| 05415067046321 | P960013 | 122 |
| 05415067046314 | P960013 | 122 |