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.
Approval of the changes to the informed consent form for the new enrollment pas registry. The pas protocol has been submitted to comply with the conditions of approval outlined in our approval order for p170003
| 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 | 2019-04-25 |
| Decision Date | 2019-06-24 |
| PMA | P170003 |
| Supplement | S008 |
| Product Code | PRC |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Ode/oir |
| 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 |