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 lutonix 035 drug coated balloon pta catheter (lutonix dcb). This device is indicated for percutaneous transluminal angioplasty, after pre-dilatation, of de novo or restenotic lesions up to 150mm in length in native superficial femoral or popliteal arteries with reference vesseldiameters of 4-6mm.
| Device | LUTONIX DRUG COATED BALLOON PTA CATETER |
| Classification Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | LUTONIX |
| Date Received | 2013-11-25 |
| Decision Date | 2014-10-09 |
| Notice Date | 2014-10-14 |
| PMA | P130024 |
| Supplement | S |
| Product Code | ONU |
| Docket Number | 14M-1597 |
| Advisory Committee | Cardiovascular |
| Expedited Review | Yes |
| Combination Product | Yes |
| Applicant Address | LUTONIX 9409 Science Center Dr new Hope, MN 55428 |
| Summary: | Summary of Safety and Effectiveness |
| Labeling: | Labeling Labeling Part 2 |
| Post-Approval Study: | Show Report Schedule and Study Progress |
| Approval Order: | Approval Order |
| 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 |