PMA P150039S004
- Device
- Tryton Side Branch Stent
- Applicant
- Poseidon Medical, Inc.
- PMA number
- P150039
- Supplement
- S004
- Product code
- MAF
- Decision date
- 2019-07-02
- Classification
- Stent, Coronary
- Generic name
- STENT, CORONARY
- Approval order statement
- Add new equipment, leak testers and hot air boxes, for use on the Tryton product during the manufacturing and testing process.
Current openFDA PMA Record#
- Device
- Tryton Side Branch Stent
- Applicant
- Poseidon Medical, Inc.
- PMA number
- P150039
- Supplement
- S004
- Product code
- MAF
- Generic name
- STENT, CORONARY
- Decision date
- 2019-07-02
- Decision code
- OK30
- Date received
- 2019-06-07
- Supplement type
- 30-Day Notice
- Supplement reason
- Process Change - Manufacturer/Sterilizer/Packager/Supplier
- Approval order statement
- Add new equipment, leak testers and hot air boxes, for use on the Tryton product during the manufacturing and testing process.