STAR EXCIMER LASER SYSTEM
FDA premarket approval P930016/S043 · decided 2014-10-02
Approval details
- PMA number
- P930016
- Supplement
- S043
- Supplement type
- Real-Time Process
- Supplement reason
- Change Design/Components/Specifications/Material
- Trade name
- STAR EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Amo Manufacturing USA, LLC
- Date received
- 2014-07-07
- Decision date
- 2014-10-02
- Days to decision
- 87 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Milpitas, CA
- Statement
- APPROVAL FOR REDESIGN OF THE STAR THYRATRON TRIGGER BOARD(P/N 0040-0044).
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