PMA P970043S001
- Device
- Ladarvision Excimer Laser System
- Applicant
- ALCON LABORATORIES
- PMA number
- P970043
- Supplement
- S001
- Decision date
- 1999-09-24
Current openFDA PMA Record
- Device
- LADARVISION EXCIMER LASER SYSTEM
- Applicant
- Alcon Laboratories
- PMA number
- P970043
- Supplement
- S001
- Product code
- LZS
- Generic name
- Excimer laser system
- Decision date
- 1999-09-24
- Decision code
- APPR
- Date received
- 1999-01-28
- Supplement type
- Normal 180 Day Track
- Supplement reason
- Labeling Change - Indications/instructions/shelf life/tradename
- Approval order statement
- Approval for the inclusion of labeling claims in the Patient Information Booklet, Physician's Booklet, and System Operation Manual regarding the effectiveness of the eye tracker component of the LADARVision(R) Excimer Laser System when used for the approved indication. Other requested modifications to the labeling included updates to data tables in the Physician's Booklet, and editorial changes and revised operational procedures in the System Operation Manual.