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.
Updates to your device labeling to communicate safety information regarding paclitaxel-coated devices for treatment of femoropopliteal arterial disease
| Device | LUTONIX 035 Drug Coated Balloon PTA Catheter |
| Classification Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Applicant | LUTONIX |
| Date Received | 2019-09-18 |
| Decision Date | 2019-10-02 |
| PMA | P170003 |
| Supplement | S012 |
| Product Code | PRC |
| Advisory Committee | Cardiovascular |
| Supplement Type | Special (immediate Track) |
| Supplement Reason | Labeling Change - Indications/instructions/shelf Life/tradename |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | LUTONIX 9409 Science Center Drive new Hope, MN 55428 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P170003 | Original Filing | |
| S025 | 2021-11-18 | 30-day Notice |
| S024 | ||
| S023 | 2021-07-06 | 30-day Notice |
| S022 | ||
| S021 | 2021-03-08 | Real-time Process |
| S020 | ||
| S019 | ||
| S018 | 2020-04-13 | 30-day Notice |
| S017 | ||
| S016 | 2020-01-21 | Real-time Process |
| S015 | 2019-11-25 | 30-day Notice |
| S014 | 2019-10-03 | Normal 180 Day Track No User Fee |
| S013 | ||
| S012 | 2019-09-18 | Special (immediate Track) |
| S011 | ||
| S010 | ||
| S009 | ||
| S008 | 2019-04-25 | Normal 180 Day Track No User Fee |
| S007 | ||
| S006 | 2019-02-26 | Real-time Process |
| S005 | ||
| S004 | 2018-10-04 | Real-time Process |
| S003 | 2018-06-20 | 30-day Notice |
| S002 | 2018-05-18 | Special (immediate Track) |
| S001 | 2017-09-25 | Normal 180 Day Track No User Fee |