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.
The revised protocol and informed consent for the new enrollment pas registry
| 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 | 2019-10-03 |
| Decision Date | 2019-11-26 |
| PMA | P170003 |
| Supplement | S014 |
| 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 |