Tryton Side Branch Stent
FDA premarket approval P150039/S005 · decided 2020-10-04
Approval details
- PMA number
- P150039
- Supplement
- S005
- Supplement type
- Normal 180 Day Track No User Fee
- Supplement reason
- Postapproval Study Protocol
- Trade name
- Tryton Side Branch Stent
- Generic name
- STENT, CORONARY
- Applicant
- Poseidon Medical, Inc.
- Date received
- 2020-09-04
- Decision date
- 2020-10-04
- Days to decision
- 30 days
- Decision code
- APPR
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pembroke Pines, FL
- Statement
- Approval for early termination of enrollment for the post-approval study (PAS) protocol.
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