TRYTON SIDE BRANCH STENT
FDA premarket approval P150039 · decided 2017-02-21
Approval details
- PMA number
- P150039
- Trade name
- TRYTON SIDE BRANCH STENT
- Generic name
- STENT, CORONARY
- Applicant
- Poseidon Medical, Inc.
- Date received
- 2015-10-30
- Decision date
- 2017-02-21
- Days to decision
- 480 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pembroke Pines, FL
- 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 expand
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