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. This device is indicated for percutaneous transluminal angioplasty (pta), after pre-dilatation, for the treatment of stenotic lesions in dysfunctional native arteriovenous dialysis fistulae that are 4 mm to 12 mm in diameter and up to 80 mm in length.
| Device | LUTONIX® 035 Drug Coated Balloon PTA Catheter, Model 9010 |
| Classification Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Applicant | LUTONIX |
| Date Received | 2017-01-23 |
| Decision Date | 2017-08-25 |
| Notice Date | 2017-09-08 |
| PMA | P170003 |
| Supplement | S |
| Product Code | PRC |
| Docket Number | 17M-5334 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | LUTONIX 9409 Science Center Drive 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 |
|---|---|---|
| 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 |