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 | MitraClip™ G4 Clip Delivery System, MitraClip™ NTR Clip Delivery System, MitraClip™ XTR Clip Delivery System |
Generic Name | Mitral Valve Repair Devices |
Applicant | Abbott Medical177 Country Road B Eastst. Paul, MN 55117 PMA NumberP100009 Supplement NumberS050 Date Received11/16/2022 Decision Date12/15/2022 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
Date Received | 2022-11-16 |
Decision Date | 2022-12-15 |
PMA | P100009 |
Supplement | S050 |
Product Code | NKM |
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 177 Country Road B East st. Paul, MN 55117 PMA NumberP100009 Supplement NumberS050 Date Received11/16/2022 Decision Date12/15/2022 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No Combination ProductNo Approval Order Statement changes To Adhesives Used In The MitraClip Clip Delivery System |
Supplement Number | Date | Supplement Type |
---|---|---|
P100009 | Original Filing | |
S051 | 2023-01-03 | 30-day Notice |
S050 | 2022-11-16 | 30-day Notice |
S049 | 2022-11-09 | 30-day Notice |
S048 | 2022-10-11 | 30-day Notice |
S047 | 2022-08-25 | 30-day Notice |
S046 | 2022-07-22 | 30-day Notice |
S045 | 2022-01-31 | Normal 180 Day Track No User Fee |
S044 | 2021-09-22 | 30-day Notice |
S043 | 2021-07-26 | 30-day Notice |
S042 | 2021-03-31 | Real-time Process |
S041 | ||
S040 | ||
S039 | 2021-02-08 | 30-day Notice |
S038 | 2021-01-25 | 30-day Notice |
S037 | 2020-01-31 | 30-day Notice |
S036 | 2019-09-03 | 30-day Notice |
S035 | 2019-08-19 | 30-day Notice |
S034 | 2019-08-06 | Special (immediate Track) |
S033 | 2019-06-28 | Special (immediate Track) |
S032 | 2019-06-24 | 30-day Notice |
S031 | ||
S030 | 2019-05-03 | Special (immediate Track) |
S029 | ||
S028 | 2018-11-06 | Panel Track |
S027 | 2018-05-31 | 135 Review Track For 30-day Notice |
S026 | 2018-05-15 | Normal 180 Day Track No User Fee |
S025 | 2017-10-24 | Normal 180 Day Track |
S024 | 2017-05-26 | 30-day Notice |
S023 | 2017-04-03 | 30-day Notice |
S022 | 2017-03-29 | 30-day Notice |
S021 | 2016-06-15 | 135 Review Track For 30-day Notice |
S020 | 2016-06-06 | 30-day Notice |
S019 | 2016-05-26 | 30-day Notice |
S018 | 2016-05-11 | Real-time Process |
S017 | 2016-03-01 | Special (immediate Track) |
S016 | 2015-11-18 | Normal 180 Day Track No User Fee |
S015 | 2015-10-01 | Normal 180 Day Track |
S014 | 2015-09-30 | 30-day Notice |
S013 | 2015-09-15 | 30-day Notice |
S012 | 2015-05-04 | Real-time Process |
S011 | 2015-04-08 | 30-day Notice |
S010 | 2015-03-30 | Normal 180 Day Track No User Fee |
S009 | 2014-11-24 | 30-day Notice |
S008 | 2014-11-19 | 30-day Notice |
S007 | 2014-07-11 | 30-day Notice |
S006 | 2014-06-16 | 30-day Notice |
S005 | 2014-05-01 | Special (immediate Track) |
S004 | 2014-04-18 | Real-time Process |
S003 | ||
S002 | 2013-11-26 | Normal 180 Day Track No User Fee |
S001 | 2013-11-26 | Normal 180 Day Track No User Fee |