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.
Approval for the mitraclip nt clip delivery system and mitraclip ntr/xtr clip delivery system for expanding the indication to include secondary mitral regurgitation. The devices, when used with maximally tolerated guideline-directed medical therapy (gdmt), are indicated for the treatment of symptomatic, moderate-to-severe or severe secondary (or functional) mitral regurgitation (mr; mr >= grade iii per american society of echocardiography criteria) in patients with a left ventricular ejection fraction (lvef) >= 20% and
| Device | MitraClip NT Clip Delivery System and MitraClip NTR/XTR Clip Delivery System |
| Classification Name | Mitral Valve Repair Devices |
| Generic Name | Mitral Valve Repair Devices |
| Applicant | ABBOTT VASCULAR INC. |
| Date Received | 2018-11-06 |
| Decision Date | 2019-03-14 |
| PMA | P100009 |
| Supplement | S028 |
| Product Code | NKM |
| Advisory Committee | Cardiovascular |
| Supplement Type | Panel Track |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | ABBOTT VASCULAR INC. 3200 Lakeside Drive santa Clara, CA 95054 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| 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 |