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 revised protocol for the post-approval study (pas) protocol.
| Device | Lutonix 035 Drug Coated Balloon PTA Catheter |
| Classification Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | LUTONIX |
| Date Received | 2017-12-08 |
| Decision Date | 2018-02-06 |
| PMA | P130024 |
| Supplement | S021 |
| Product Code | ONU |
| 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 | Normal 180 Day Track No User Fee |
| Supplement Reason | Postapproval Study Protocol - Osb |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | LUTONIX 9409 Science Center Dr new Hope, MN 55428 |
| 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 |