| Note: 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. |
| |
| Device | TRYTON SIDE BRANCH STENT |
|---|
| Generic Name | STENT, CORONARY |
|---|
| Applicant | Poseidon Medical Inc.
1125 NW 132nd Avenue
Pembroke Pines, FL 33028 |
|---|
| PMA Number | P150039 |
|---|
| Date Received | 10/30/2015 |
|---|
| Decision Date | 02/21/2017 |
|---|
| Product Code |
MAF |
| Docket Number | 17M-1121 |
|---|
| Notice Date | 02/27/2017 |
|---|
| Advisory Committee |
Cardiovascular |
|---|
| Clinical Trials | NCT01258972
|
|---|
| Expedited Review Granted? | No |
|---|
| Combination Product | No |
|---|
Approval Order Statement
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 <=5.0 mm, along with reference vessel diameters >=2.5 mm to <=3.5 mm in the side branch and >=2.5 mm to <=4.0 mm in the main branch. The device is intended for use in conjunction with commercially available balloon expandable drug-eluting coronary stents in the main branch. |
| Approval Order | Approval Order |
|---|
| Summary | Summary of Safety and Effectiveness |
|---|
| Labeling | Labeling
Labeling Part 2 |
|---|
| Post-Approval Study | Show Report Schedule and Study Progress |
|---|
| Supplements: |
S001 S002 S003 S004 S005 |
|
|
