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 for the tryton side branch stent. This device is indicated for improving the side branch luminal diameter of de novo native coronary artery bifurcation lesions (medina classification 1. 1. 1; 0. 1. 1; 1. 0. 1) with a side branch diameter stenosis of >=50% and a lesion length =2. 5 mm to =2. 5 mm to
| Device | TRYTON SIDE BRANCH STENT |
| Classification Name | Stent, Coronary |
| Generic Name | Stent, Coronary |
| Applicant | TRYTON MEDICAL, INC. |
| Date Received | 2015-10-30 |
| Decision Date | 2017-02-21 |
| Notice Date | 2017-02-27 |
| PMA | P150039 |
| Supplement | S |
| Product Code | MAF |
| Docket Number | 17M-1121 |
| Advisory Committee | Cardiovascular |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | TRYTON MEDICAL, INC. 1000 Park 40 Plaza Suite 325 durham, NC 27713 |
| 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 |
|---|---|---|
| P150039 | Original Filing | |
| S005 | 2020-09-04 | Normal 180 Day Track No User Fee |
| S004 | 2019-06-07 | 30-day Notice |
| S003 | 2017-09-29 | Normal 180 Day Track No User Fee |
| S002 | 2017-07-11 | 30-day Notice |
| S001 | 2017-03-13 | Normal 180 Day Track No User Fee |
| Device ID | PMA | Supp |
|---|---|---|
| 00894588002187 | P150039 | 000 |
| 00894588002170 | P150039 | 000 |
| 00894588002163 | P150039 | 000 |
| 00894588002156 | P150039 | 000 |
| 00894588002149 | P150039 | 000 |
| 00894588002132 | P150039 | 000 |
| 00894588002125 | P150039 | 000 |