This medical device has supplements. The device description/function or indication may have changed. Be sure to look at the supplements to get an up-to-date information on device changes. The labeling included below is the version at time of approval of the original pma or panel track supplement and may not represent the most recent labeling.
Approval for the mitraclip clip delivery system (mitraclip cds). This device is indicated for the percutaneous reduction ofsignificant symptomatic mitral regurgitation (mr >= 3+) due to primary abnormality of the mitral apparatus [degenerative mr] in patients who have been determined to be at prohibitive risk for mitral valve surgery by a heart team, which includes a cardiac surgeon experienced in mitral valve surgery and a cardiologist experienced in mitral valve disease, and in whom existing comorbidities would not preclude the expected benefit from reduction of the mitral regurgitation.
| Device | MITRACLIP DELIVERY SYSTEM |
| Classification Name | Mitral Valve Repair Devices |
| Generic Name | Mitral Valve Repair Devices |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2010-03-04 |
| Decision Date | 2013-10-24 |
| Notice Date | 2013-11-15 |
| PMA | P100009 |
| Supplement | S |
| Product Code | NKM |
| Docket Number | 13M-1365 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |