TRYTON Side Branch Stent
FDA premarket approval P150039/S003 · decided 2018-03-28
Approval details
- PMA number
- P150039
- Supplement
- S003
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Labeling Change - PAS
- Trade name
- TRYTON Side Branch Stent
- Generic name
- STENT, CORONARY
- Applicant
- Poseidon Medical, Inc.
- Date received
- 2017-09-29
- Decision date
- 2018-03-28
- Days to decision
- 180 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pembroke Pines, FL
- Statement
- Approval for updates to the labeling to include complete follow-up for the Pivotal RCT and EA Confirmatory Studies.
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