Tryton Side Branch Stent
FDA premarket approval P150039/S004 · decided 2019-07-02
Approval details
- PMA number
- P150039
- Supplement
- S004
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Trade name
- Tryton Side Branch Stent
- Generic name
- STENT, CORONARY
- Applicant
- Poseidon Medical, Inc.
- Date received
- 2019-06-07
- Decision date
- 2019-07-02
- Days to decision
- 25 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pembroke Pines, FL
- Statement
- Add new equipment, leak testers and hot air boxes, for use on the Tryton product during the manufacturing and testing process.
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