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 the frequency of endotoxin monitoring.
| Device | Lutonix Drug Coated Balloon |
| Classification Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-coated Peripheral Transluminal Angioplasty Catheter |
| Applicant | LUTONIX |
| Date Received | 2018-06-20 |
| Decision Date | 2018-06-28 |
| PMA | P170003 |
| Supplement | S003 |
| Product Code | PRC |
| Docket Number | Premarket Approval (PMA) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices Radia |
| 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 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 |