INFINITY LS EXCIMER LASER SYSTEM
FDA premarket approval P930034/S015 · decided 2000-02-03
Approval details
- PMA number
- P930034
- Supplement
- S015
- Supplement type
- Special (Immediate Track)
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Trade name
- INFINITY LS EXCIMER LASER SYSTEM
- Generic name
- Excimer laser system
- Applicant
- Alcon Laboratories, Inc.
- Date received
- 2000-01-06
- Decision date
- 2000-02-03
- Days to decision
- 28 days
- Decision code
- APPR
- Product code
- LZS
- Advisory committee
- Ophthalmic
- Expedited review
- No
- Location
- Orlando, FL
- Statement
- Change tradename to Infinity LS Excimer Laser System
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