Tryton Side Branch Stent
FDA premarket approval P150039/S002 · decided 2017-08-10
Approval details
- PMA number
- P150039
- Supplement
- S002
- 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
- 2017-07-11
- Decision date
- 2017-08-10
- Days to decision
- 30 days
- Decision code
- OK30
- Product code
- MAF
- Advisory committee
- Cardiovascular
- Expedited review
- No
- Location
- Pembroke Pines, FL
- Statement
- Replace the pouch sealer equipment and to modify the sealer process parameters.
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