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.
Change in mixing ball used in the coating solution preparation process
| Device | Lutonix 035 Drug Coated Balloon PTA Catheter |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | LUTONIX |
| Date Received | 2020-04-13 |
| Decision Date | 2020-05-04 |
| PMA | P130024 |
| Supplement | S036 |
| Product Code | ONU |
| Advisory Committee | Cardiovascular |
| Supplement Type | 30-day Notice |
| Supplement Reason | Process Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | LUTONIX 9409 Science Center Dr new Hope, MN 55428 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P130024 | Original Filing | |
| S042 | 2021-11-18 | 30-day Notice |
| S041 | 2021-07-06 | 30-day Notice |
| S040 | 2021-03-08 | Real-time Process |
| S039 | ||
| S038 | ||
| S037 | 2020-09-30 | Real-time Process |
| S036 | 2020-04-13 | 30-day Notice |
| S035 | ||
| S034 | ||
| S033 | 2019-11-29 | Real-time Process |
| S032 | 2019-11-25 | 30-day Notice |
| S031 | ||
| S030 | 2019-09-20 | Normal 180 Day Track |
| S029 | 2019-09-03 | Special (immediate Track) |
| S028 | ||
| S027 | 2019-02-26 | Real-time Process |
| S026 | 2018-11-16 | Real-time Process |
| S025 | 2018-10-04 | Real-time Process |
| S024 | 2018-06-25 | Real-time Process |
| S023 | 2018-06-20 | 30-day Notice |
| S022 | 2018-01-25 | Normal 180 Day Track |
| S021 | 2017-12-08 | Normal 180 Day Track No User Fee |
| S020 | 2017-09-25 | Normal 180 Day Track No User Fee |
| S019 | ||
| S018 | 2017-02-06 | 30-day Notice |
| S017 | 2016-11-28 | 30-day Notice |
| S016 | ||
| S015 | 2016-08-15 | Normal 180 Day Track No User Fee |
| S014 | 2016-07-05 | Normal 180 Day Track |
| S013 | 2016-06-15 | Normal 180 Day Track No User Fee |
| S012 | 2016-04-29 | Special (immediate Track) |
| S011 | 2016-03-25 | Normal 180 Day Track No User Fee |
| S010 | 2016-01-27 | Real-time Process |
| S009 | 2016-01-04 | Panel Track |
| S008 | 2015-11-09 | Special (immediate Track) |
| S007 | 2015-08-07 | Special (immediate Track) |
| S006 | 2015-07-13 | Normal 180 Day Track No User Fee |
| S005 | 2015-06-02 | Normal 180 Day Track |
| S004 | 2015-03-02 | Real-time Process |
| S003 | 2015-02-25 | 135 Review Track For 30-day Notice |
| S002 | 2015-01-12 | Normal 180 Day Track |
| S001 | 2014-11-24 | Real-time Process |