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 of the stellarex 0. 035 otw drug-coated angioplasty balloon. This device is indicated for percutaneous transluminal angioplasty (pta), after appropriate vessel preparation, of de novo or restenotic lesions up to 180 mm in length in native superficial femoral or popliteal arteries with reference vessel diameters of 4-6 mm.
| Device | STELLAREX 0.035 OTW DRUG-COATED ANGIOPLASTY BALLOON |
| Classification Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Generic Name | Drug-eluting Peripheral Transluminal Angioplasty Catheter |
| Applicant | The Spectranetics Corp. |
| Date Received | 2016-11-02 |
| Decision Date | 2017-07-26 |
| Notice Date | 2017-07-28 |
| PMA | P160049 |
| Supplement | S |
| Product Code | ONU |
| Docket Number | 17M-4498 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | Yes |
| Applicant Address | The Spectranetics Corp. 6531 Dumbarton Circle fremont, CA 94555 |
| 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 |
|---|---|---|
| P160049 | Original Filing | |
| S019 | 2022-06-14 | 30-day Notice |
| S018 | 2022-04-01 | Normal 180 Day Track No User Fee |
| S017 | 2022-03-17 | 30-day Notice |
| S016 | ||
| S015 | 2021-09-29 | Panel Track |
| S014 | ||
| S013 | 2021-09-17 | Normal 180 Day Track No User Fee |
| S012 | 2021-05-07 | Normal 180 Day Track No User Fee |
| S011 | 2021-01-21 | 30-day Notice |
| S010 | ||
| S009 | ||
| S008 | 2020-01-15 | 30-day Notice |
| S007 | 2019-09-03 | Special (immediate Track) |
| S006 | 2019-05-13 | 30-day Notice |
| S005 | 2019-04-08 | 30-day Notice |
| S004 | ||
| S003 | 2018-10-01 | Normal 180 Day Track No User Fee |
| S002 | 2018-01-22 | Real-time Process |
| S001 | 2017-09-01 | Real-time Process |