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 NumberS049 Date Received11/09/2022 Decision Date11/20/2022 Product Code NKM Advisory Committee Cardiovascular Supplement Type30-day Notice Supplement Reason Process Change - Manufacturer/sterilizer/packager/supplier Expedited Review Granted? No |
| Date Received | 2022-11-09 |
| Decision Date | 2022-11-20 |
| PMA | P100009 |
| Supplement | S049 |
| 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 NumberS049 Date Received11/09/2022 Decision Date11/20/2022 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 to Modify The Flexural Rigidity Acceptance Criteria For The MitraClip Delivery Catheter Shaft Component |
| 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 |